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The function works with procotol- and results- related information. It converts lists and other values that are in a data frame returned by dbGetFieldsIntoDf into individual rows of a long data frame. From the resulting data frame, values of interest can be selected using dfName2Value. The function is intended for fields with complex content, such as node field "clinical_results" from EUCTR, which dbGetFieldsIntoDf returns as a multiply nested list and for which this function then converts every observation of every (leaf) field into a row of its own.

Usage

dfTrials2Long(df)

Arguments

df

Data frame (or tibble) with columns including the trial identifier (_id) and one or more variables as obtained from dbGetFieldsIntoDf

Value

A data frame (or tibble, if dplyr is loaded) with the four columns: `_id`, `identifier`, `name`, `value`

Examples


dbc <- nodbi::src_sqlite(
   dbname = system.file("extdata", "demo.sqlite", package = "ctrdata"),
   collection = "my_trials")

dfwide <- dbGetFieldsIntoDf(
  fields = "clinical_results.participant_flow",
  con = dbc)
#> clinical_results.participant_flow... 
#>     
#> . 

dfTrials2Long(df = dfwide)
#> clinical_results.participant_flow                                                                                                                                                                       

#>                                                                                                                                                                                                         

#> . 
#> . 
#> . 
#> . 
#> . 
#> 
#> Total 342 rows, 13 unique names of variables
#>             _id identifier
#> 1   NCT01389856          0
#> 2   NCT01389856          0
#> 3   NCT01389856          1
#> 4   NCT01389856          2
#> 5   NCT01389856          1
#> 6   NCT01389856          2
#> 7   NCT01389856          1
#> 8   NCT01389856          2
#> 9   NCT01389856          0
#> 10  NCT01389856          1
#> 11  NCT01389856          2
#> 12  NCT01389856          3
#> 13  NCT01389856         11
#> 14  NCT01389856         12
#> 15  NCT01389856        2.1
#> 16  NCT01389856        2.2
#> 17  NCT01389856        2.1
#> 18  NCT01389856        2.2
#> 19  NCT01389856        3.1
#> 20  NCT01389856        3.2
#> 21  NCT01389856        3.1
#> 22  NCT01389856        3.2
#> 23  NCT01490580          0
#> 24  NCT01490580          1
#> 25  NCT01490580          2
#> 26  NCT01490580          1
#> 27  NCT01490580          2
#> 28  NCT01490580          1
#> 29  NCT01490580          2
#> 30  NCT01490580          0
#> 31  NCT01490580          1
#> 32  NCT01490580          2
#> 33  NCT01490580          3
#> 34  NCT01490580        1.1
#> 35  NCT01490580        1.2
#> 36  NCT01490580        1.1
#> 37  NCT01490580        1.2
#> 38  NCT01490580        2.1
#> 39  NCT01490580        2.2
#> 40  NCT01490580        2.1
#> 41  NCT01490580        2.2
#> 42  NCT01490580        3.1
#> 43  NCT01490580        3.2
#> 44  NCT01490580        3.1
#> 45  NCT01490580        3.2
#> 46  NCT01490580          0
#> 47  NCT01490580          1
#> 48  NCT01490580          2
#> 49  NCT01490580          1
#> 50  NCT01490580          2
#> 51  NCT01555957          1
#> 52  NCT01555957          2
#> 53  NCT01555957          1
#> 54  NCT01555957          2
#> 55  NCT01555957          1
#> 56  NCT01555957          2
#> 57  NCT01555957          0
#> 58  NCT01555957          1
#> 59  NCT01555957          2
#> 60  NCT01555957          3
#> 61  NCT01555957        1.1
#> 62  NCT01555957        1.2
#> 63  NCT01555957        1.1
#> 64  NCT01555957        1.2
#> 65  NCT01555957        2.1
#> 66  NCT01555957        2.2
#> 67  NCT01555957        2.1
#> 68  NCT01555957        2.2
#> 69  NCT01555957        3.1
#> 70  NCT01555957        3.2
#> 71  NCT01555957        3.1
#> 72  NCT01555957        3.2
#> 73  NCT01720524          0
#> 74  NCT01720524          0
#> 75  NCT01720524          1
#> 76  NCT01720524          2
#> 77  NCT01720524          1
#> 78  NCT01720524          2
#> 79  NCT01720524          1
#> 80  NCT01720524          2
#> 81  NCT01720524          1
#> 82  NCT01720524          2
#> 83  NCT01720524        1.1
#> 84  NCT01720524        1.2
#> 85  NCT01720524        1.3
#> 86  NCT01720524      1.1.1
#> 87  NCT01720524      1.1.2
#> 88  NCT01720524      1.1.1
#> 89  NCT01720524      1.1.2
#> 90  NCT01720524      1.2.1
#> 91  NCT01720524      1.2.2
#> 92  NCT01720524      1.2.1
#> 93  NCT01720524      1.2.2
#> 94  NCT01720524      1.3.1
#> 95  NCT01720524      1.3.2
#> 96  NCT01720524      1.3.1
#> 97  NCT01720524      1.3.2
#> 98  NCT01720524        2.1
#> 99  NCT01720524        2.2
#> 100 NCT01720524        2.3
#> 101 NCT01720524       2.11
#> 102 NCT01720524       2.12
#> 103 NCT01720524      2.2.1
#> 104 NCT01720524      2.2.2
#> 105 NCT01720524      2.2.1
#> 106 NCT01720524      2.2.2
#> 107 NCT01720524      2.3.1
#> 108 NCT01720524      2.3.2
#> 109 NCT01720524      2.3.1
#> 110 NCT01720524      2.3.2
#> 111 NCT01720524        1.1
#> 112 NCT01720524        1.2
#> 113 NCT01720524        1.3
#> 114 NCT01720524        1.4
#> 115 NCT01720524        1.5
#> 116 NCT01720524        1.6
#> 117 NCT01720524        1.7
#> 118 NCT01720524        1.8
#> 119 NCT01720524      1.1.1
#> 120 NCT01720524      1.1.2
#> 121 NCT01720524      1.1.1
#> 122 NCT01720524      1.1.2
#> 123 NCT01720524      1.2.1
#> 124 NCT01720524      1.2.2
#> 125 NCT01720524      1.2.1
#> 126 NCT01720524      1.2.2
#> 127 NCT01720524      1.3.1
#> 128 NCT01720524      1.3.2
#> 129 NCT01720524      1.3.1
#> 130 NCT01720524      1.3.2
#> 131 NCT01720524      1.4.1
#> 132 NCT01720524      1.4.2
#> 133 NCT01720524      1.4.1
#> 134 NCT01720524      1.4.2
#> 135 NCT01720524      1.5.1
#> 136 NCT01720524      1.5.2
#> 137 NCT01720524      1.5.1
#> 138 NCT01720524      1.5.2
#> 139 NCT01720524      1.6.1
#> 140 NCT01720524      1.6.2
#> 141 NCT01720524      1.6.1
#> 142 NCT01720524      1.6.2
#> 143 NCT01720524      1.7.1
#> 144 NCT01720524      1.7.2
#> 145 NCT01720524      1.7.1
#> 146 NCT01720524      1.7.2
#> 147 NCT01720524      1.8.1
#> 148 NCT01720524      1.8.2
#> 149 NCT01720524      1.8.1
#> 150 NCT01720524      1.8.2
#> 151 NCT01720524        2.1
#> 152 NCT01720524        2.2
#> 153 NCT01720524        2.3
#> 154 NCT01720524        2.4
#> 155 NCT01720524      2.1.1
#> 156 NCT01720524      2.1.2
#> 157 NCT01720524      2.1.1
#> 158 NCT01720524      2.1.2
#> 159 NCT01720524      2.2.1
#> 160 NCT01720524      2.2.2
#> 161 NCT01720524      2.2.1
#> 162 NCT01720524      2.2.2
#> 163 NCT01720524      2.3.1
#> 164 NCT01720524      2.3.2
#> 165 NCT01720524      2.3.1
#> 166 NCT01720524      2.3.2
#> 167 NCT01720524      2.4.1
#> 168 NCT01720524      2.4.2
#> 169 NCT01720524      2.4.1
#> 170 NCT01720524      2.4.2
#> 171 NCT01783041          0
#> 172 NCT01783041          1
#> 173 NCT01783041          2
#> 174 NCT01783041          1
#> 175 NCT01783041          2
#> 176 NCT01783041          1
#> 177 NCT01783041          2
#> 178 NCT01783041          1
#> 179 NCT01783041          2
#> 180 NCT01783041        1.1
#> 181 NCT01783041        1.2
#> 182 NCT01783041        1.3
#> 183 NCT01783041      1.1.1
#> 184 NCT01783041      1.1.2
#> 185 NCT01783041      1.1.1
#> 186 NCT01783041      1.1.2
#> 187 NCT01783041      1.2.1
#> 188 NCT01783041      1.2.2
#> 189 NCT01783041      1.2.1
#> 190 NCT01783041      1.2.2
#> 191 NCT01783041      1.3.1
#> 192 NCT01783041      1.3.2
#> 193 NCT01783041      1.3.1
#> 194 NCT01783041      1.3.2
#> 195 NCT01783041        2.1
#> 196 NCT01783041        2.2
#> 197 NCT01783041        2.3
#> 198 NCT01783041      2.1.1
#> 199 NCT01783041      2.1.2
#> 200 NCT01783041      2.1.1
#> 201 NCT01783041      2.1.2
#> 202 NCT01783041      2.2.1
#> 203 NCT01783041      2.2.2
#> 204 NCT01783041      2.2.1
#> 205 NCT01783041      2.2.2
#> 206 NCT01783041      2.3.1
#> 207 NCT01783041      2.3.2
#> 208 NCT01783041      2.3.1
#> 209 NCT01783041      2.3.2
#> 210 NCT01899677          1
#> 211 NCT01899677          2
#> 212 NCT01899677          1
#> 213 NCT01899677          2
#> 214 NCT01899677          1
#> 215 NCT01899677          2
#> 216 NCT01899677          0
#> 217 NCT01899677          1
#> 218 NCT01899677          2
#> 219 NCT01899677          3
#> 220 NCT01899677        1.1
#> 221 NCT01899677        1.2
#> 222 NCT01899677        1.1
#> 223 NCT01899677        1.2
#> 224 NCT01899677        2.1
#> 225 NCT01899677        2.2
#> 226 NCT01899677        2.1
#> 227 NCT01899677        2.2
#> 228 NCT01899677        3.1
#> 229 NCT01899677        3.2
#> 230 NCT01899677        3.1
#> 231 NCT01899677        3.2
#> 232 NCT01954082          0
#> 233 NCT01954082          1
#> 234 NCT01954082          2
#> 235 NCT01954082          1
#> 236 NCT01954082          2
#> 237 NCT01954082          1
#> 238 NCT01954082          2
#> 239 NCT01954082          0
#> 240 NCT01954082          1
#> 241 NCT01954082          2
#> 242 NCT01954082          3
#> 243 NCT01954082          4
#> 244 NCT01954082        1.1
#> 245 NCT01954082        1.2
#> 246 NCT01954082        1.1
#> 247 NCT01954082        1.2
#> 248 NCT01954082         21
#> 249 NCT01954082         22
#> 250 NCT01954082         31
#>                                                                                                                                            name
#> 1                                                                                         clinical_results.participant_flow.recruitment_details
#> 2                                                                                      clinical_results.participant_flow.pre_assignment_details
#> 3                                                                                   clinical_results.participant_flow.group_list.group.group_id
#> 4                                                                                   clinical_results.participant_flow.group_list.group.group_id
#> 5                                                                                      clinical_results.participant_flow.group_list.group.title
#> 6                                                                                      clinical_results.participant_flow.group_list.group.title
#> 7                                                                                clinical_results.participant_flow.group_list.group.description
#> 8                                                                                clinical_results.participant_flow.group_list.group.description
#> 9                                                                                    clinical_results.participant_flow.period_list.period.title
#> 10                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 11                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 12                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 13                                 clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 14                                 clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 15                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 16                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 17                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 18                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 19                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 20                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 21                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 22                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 23                                                                                        clinical_results.participant_flow.recruitment_details
#> 24                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 25                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 26                                                                                     clinical_results.participant_flow.group_list.group.title
#> 27                                                                                     clinical_results.participant_flow.group_list.group.title
#> 28                                                                               clinical_results.participant_flow.group_list.group.description
#> 29                                                                               clinical_results.participant_flow.group_list.group.description
#> 30                                                                                   clinical_results.participant_flow.period_list.period.title
#> 31                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 32                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 33                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 34                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 35                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 36                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 37                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 38                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 39                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 40                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 41                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 42                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 43                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 44                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 45                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 46                                    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 47  clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 48  clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 49     clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 50     clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 51                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 52                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 53                                                                                     clinical_results.participant_flow.group_list.group.title
#> 54                                                                                     clinical_results.participant_flow.group_list.group.title
#> 55                                                                               clinical_results.participant_flow.group_list.group.description
#> 56                                                                               clinical_results.participant_flow.group_list.group.description
#> 57                                                                                   clinical_results.participant_flow.period_list.period.title
#> 58                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 59                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 60                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 61                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 62                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 63                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 64                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 65                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 66                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 67                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 68                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 69                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 70                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 71                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 72                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 73                                                                                        clinical_results.participant_flow.recruitment_details
#> 74                                                                                     clinical_results.participant_flow.pre_assignment_details
#> 75                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 76                                                                                  clinical_results.participant_flow.group_list.group.group_id
#> 77                                                                                     clinical_results.participant_flow.group_list.group.title
#> 78                                                                                     clinical_results.participant_flow.group_list.group.title
#> 79                                                                               clinical_results.participant_flow.group_list.group.description
#> 80                                                                               clinical_results.participant_flow.group_list.group.description
#> 81                                                                                   clinical_results.participant_flow.period_list.period.title
#> 82                                                                                   clinical_results.participant_flow.period_list.period.title
#> 83                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 84                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 85                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 86                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 87                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 88                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 89                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 90                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 91                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 92                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 93                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 94                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 95                        clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 96                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 97                           clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 98                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 99                                                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 100                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 101                                clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 102                                clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 103                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 104                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 105                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 106                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 107                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 108                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 109                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 110                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 111                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 112                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 113                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 114                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 115                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 116                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 117                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 118                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 119 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 120 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 121    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 122    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 123 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 124 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 125    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 126    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 127 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 128 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 129    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 130    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 131 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 132 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 133    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 134    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 135 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 136 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 137    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 138    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 139 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 140 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 141    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 142    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 143 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 144 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 145    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 146    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 147 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 148 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 149    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 150    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 151                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 152                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 153                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 154                                   clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.title
#> 155 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 156 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 157    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 158    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 159 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 160 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 161    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 162    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 163 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 164 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 165    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 166    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 167 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 168 clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.group_id
#> 169    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 170    clinical_results.participant_flow.period_list.period.drop_withdraw_reason_list.drop_withdraw_reason.participants_list.participants.count
#> 171                                                                                       clinical_results.participant_flow.recruitment_details
#> 172                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 173                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 174                                                                                    clinical_results.participant_flow.group_list.group.title
#> 175                                                                                    clinical_results.participant_flow.group_list.group.title
#> 176                                                                              clinical_results.participant_flow.group_list.group.description
#> 177                                                                              clinical_results.participant_flow.group_list.group.description
#> 178                                                                                  clinical_results.participant_flow.period_list.period.title
#> 179                                                                                  clinical_results.participant_flow.period_list.period.title
#> 180                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 181                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 182                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 183                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 184                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 185                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 186                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 187                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 188                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 189                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 190                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 191                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 192                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 193                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 194                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 195                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 196                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 197                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 198                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 199                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 200                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 201                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 202                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 203                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 204                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 205                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 206                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 207                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 208                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 209                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 210                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 211                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 212                                                                                    clinical_results.participant_flow.group_list.group.title
#> 213                                                                                    clinical_results.participant_flow.group_list.group.title
#> 214                                                                              clinical_results.participant_flow.group_list.group.description
#> 215                                                                              clinical_results.participant_flow.group_list.group.description
#> 216                                                                                  clinical_results.participant_flow.period_list.period.title
#> 217                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 218                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 219                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 220                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 221                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 222                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 223                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 224                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 225                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 226                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 227                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 228                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 229                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 230                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 231                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 232                                                                                       clinical_results.participant_flow.recruitment_details
#> 233                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 234                                                                                 clinical_results.participant_flow.group_list.group.group_id
#> 235                                                                                    clinical_results.participant_flow.group_list.group.title
#> 236                                                                                    clinical_results.participant_flow.group_list.group.title
#> 237                                                                              clinical_results.participant_flow.group_list.group.description
#> 238                                                                              clinical_results.participant_flow.group_list.group.description
#> 239                                                                                  clinical_results.participant_flow.period_list.period.title
#> 240                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 241                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 242                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 243                                                         clinical_results.participant_flow.period_list.period.milestone_list.milestone.title
#> 244                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 245                       clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.group_id
#> 246                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 247                          clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants.count
#> 248                                clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 249                                clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#> 250                                clinical_results.participant_flow.period_list.period.milestone_list.milestone.participants_list.participants
#>                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   value
#> 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      First patient, first visit was 8 December 2011 and last patient, last visit was 5 December 2013. The investigational sites were tertiary care centers with neonatal intensive care unit facilities at which inhaled nitric oxide (iNO) was used as standard of care for persistent pulmonary hypertension of the newborn (PPHN).
#> 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Term or near-term (gestational age > 34 weeks) hypoxic newborns with respiratory distress refractory to supplemental oxygen were considered, provided they had no significant structural cardiac anomalies documented in the pre-natal period and had no immediate need for extra corporeal membrane oxygenation (ECMO).
#> 3                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    P1
#> 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    P2
#> 5                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Bosentan
#> 6                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Placebo
#> 7                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Bosentan\rBosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube.
#> 8                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Matching placebo\rMatching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube.
#> 9                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Overall Study
#> 10                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              STARTED
#> 11                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            COMPLETED
#> 12                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        NOT COMPLETED
#> 13                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Randomized and treated. An additional 2 patients were randomized but not treated.
#> 14                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Randomized and treated.
#> 15                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 16                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 17                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   13
#> 18                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    8
#> 19                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 20                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 21                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 22                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 23                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     The trial was prematurely interrupted for logistic reasons in July 2016: a fourth drug manufacturing run was necessary because the intralipids had passed their expiration date and funding had run out. During the study period, 755 patients were screened for eligibility, and 173 randomized
#> 24                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 25                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 26                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Atropine Atracurium Sufentanil
#> 27                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Atropine Propofol
#> 28                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           n=82 allocated to atropine+atracurium+sufentanil\rn=80 received allocated intervention\rn=2 did not receive allocated intervention\rn=1 never intubated\rn=1 received another premedication\r82 included in final analysis
#> 29                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     n=91 allocated to atropine+propofol\rn= 2 excluded for lack of consent\rn=83 received allocated intervention\rn=6 did not receive allocated intervention\rn=2 never intubated\rn=4 received another premedication\r89 included in final analysis
#> 30                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Overall Study
#> 31                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              STARTED
#> 32                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            COMPLETED
#> 33                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        NOT COMPLETED
#> 34                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 35                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 36                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   82
#> 37                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   91
#> 38                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 39                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 40                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   82
#> 41                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   89
#> 42                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 43                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 44                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 45                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    2
#> 46                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Parents withdrew consent
#> 47                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 48                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 49                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 50                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    2
#> 51                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 52                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 53                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Low Dose Intravenous Lipids
#> 54                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      High Dose of Intravenous Lipids
#> 55                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               intravenous lipid: intravenous given daily for 6 weeks
#> 56                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               intravenous lipid: intravenous given daily for 6 weeks
#> 57                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Overall Study
#> 58                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              STARTED
#> 59                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            COMPLETED
#> 60                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        NOT COMPLETED
#> 61                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 62                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 63                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   20
#> 64                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   20
#> 65                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 66                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 67                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   20
#> 68                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   20
#> 69                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 70                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 71                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 72                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    0
#> 73                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      This study was planned in two parts Part A (double-blind phase) and Part B (long-term, non-intervention phase).
#> 74                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure (HRF) and at risk of PPHN who were receiving inhaled nitric oxide (iNO) treatment were evaluated in this study.
#> 75                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 76                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 77                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        IV Sildenafil
#> 78                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Placebo
#> 79                                                                                                                                                                                                                                                Part A: Participants received sildenafil intravenously based on their body weight at a loading dose of 0.1 milligrams per kg (mg/kg) for 30 minutes on Day 1 followed by a maintenance dose of 0.03 milligrams per kg per hour (mg/kg/hr), for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
#> 80                                                                                                                                                                                                                                                                                                                               Participants received placebo (0.9 % normal saline or dextrose 10%) at a rate matched to sildenafil infusion, intravenously, based on participant's weight, for a minimum of 2 days and maximum of 14 days. Infusion continuation was upon investigator discretion in view of participants' safety and well-being. Part B: Participants who started Part A (not necessarily completed Part A) and who were eligible and consented, continued to be followed up in part B of the study.
#> 81                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Part A
#> 82                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Part B
#> 83                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              STARTED
#> 84                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            COMPLETED
#> 85                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        NOT COMPLETED
#> 86                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 87                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 88                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   29
#> 89                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   30
#> 90                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 91                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 92                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   22
#> 93                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   18
#> 94                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P1
#> 95                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   P2
#> 96                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    7
#> 97                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   12
#> 98                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              STARTED
#> 99                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            COMPLETED
#> 100                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       NOT COMPLETED
#> 101                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Participants who did not complete Part A could also participate in Part B.
#> 102                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Participants who did not complete Part A could also participate in Part B.
#> 103                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 104                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 105                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  22
#> 106                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  17
#> 107                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 108                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 109                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   5
#> 110                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   9
#> 111                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Insufficient Clinical Response
#> 112                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Adverse Event
#> 113                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Death
#> 114                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Lost to Follow-up
#> 115                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Missed 28 day follow-up visit
#> 116                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Withdrawal by Subject
#> 117                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Other
#> 118                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Lost to Follow-up
#> 119                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 120                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 121                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 122                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   4
#> 123                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 124                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 125                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 126                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 127                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 128                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 129                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 130                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 131                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 132                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 133                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 134                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 135                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 136                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 137                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 138                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 139                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 140                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 141                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 142                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 143                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 144                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 145                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 146                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 147                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 148                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 149                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 150                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 151                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           No longer willing to participate in study
#> 152                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Other
#> 153                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Lost to Follow-up
#> 154                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Death
#> 155                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 156                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 157                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 158                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   4
#> 159                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 160                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 161                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 162                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 163                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 164                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 165                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 166                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   3
#> 167                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 168                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 169                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   0
#> 170                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   2
#> 171                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Infants born at <32 weeks gestation admitted to the Neonatal Intensive Care Unit (NICU) at Weiler and Wakefield Divisions of Montefiore Medical Center were enrolled in this study.
#> 172                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 173                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 174                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         5% Dextrose
#> 175                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         L-carnitine
#> 176                                                                                                                                   Infants randomized to the placebo group will receive 5% dextrose intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of placebo (5% Dextrose) will be given to the study patients.\r5% Dextrose: Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients.
#> 177                                                                                                                                                                              Infants randomized to the study group will receive L-carnitine intravenously. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.\rL-carnitine: Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.
#> 178                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               First 2 Weeks of Life
#> 179                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             NNNS Examination at Term Equivalent Age
#> 180                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             STARTED
#> 181                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           COMPLETED
#> 182                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       NOT COMPLETED
#> 183                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 184                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 185                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  72
#> 186                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  72
#> 187                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 188                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 189                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  69
#> 190                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  71
#> 191                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 192                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 193                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   3
#> 194                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   1
#> 195                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             STARTED
#> 196                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           COMPLETED
#> 197                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       NOT COMPLETED
#> 198                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 199                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 200                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  69
#> 201                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  71
#> 202                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 203                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 204                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  60
#> 205                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  59
#> 206                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 207                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 208                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   9
#> 209                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  12
#> 210                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 211                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 212                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Symbiotic
#> 213                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Distilled Water
#> 214                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 symbiotic preparation 1/2 sachet twice daily during 30 days\rsymbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
#> 215                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             2 x 0.5 cc distilled water will be given during 30 days\rdistilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
#> 216                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Overall Study
#> 217                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             STARTED
#> 218                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           COMPLETED
#> 219                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       NOT COMPLETED
#> 220                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 221                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 222                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  35
#> 223                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  35
#> 224                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 225                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 226                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  25
#> 227                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  28
#> 228                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 229                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 230                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  10
#> 231                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   7
#> 232                                                                                                                                                                                                                                                                                                                                                                                                                                                                               From April 2014 to September 2015, infants born before 28 weeks gestation and surviving >12 hours were screened when admitted to one of the 18 NICHD NRN Centers (approximately 44 sites) in the United States and enrolled in the study if they met the eligibility criteria and consent was obtained before 72 hours postnatal age.
#> 233                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 234                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 235                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Myo-Inositol 5% Injection
#> 236                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                5% Glucose(Dextrose)
#> 237 Inositol (i.e myo-Inositol) 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. The medication is administered twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose) begining within 12-72 hours of birth and continuing until the earliest of 34 weeks postmenstrual age (PMA), 10 weeks chronologic age, or the time of discharge. The doses are administered intravenously (IV) using syringe pump over 15-30 minutes until enteral feeds reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally.
#> 238                                                                                                                                                                                                                                                                                                                                                                                                                                                                   The placebo is 5% dextrose (5% glucose) in sterile water (D5W pyrogen and preservative free) United States Pharmacopoeia (USP) for IV infusion. The placebo is administered in the same dose (80 mg glucose/kg/day divided in 2 doses administered every 12 hours) and dispensed in the same manner (intravenously or enterally) as the inositol.
#> 239                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Overall Study
#> 240                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             STARTED
#> 241                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Treated
#> 242                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           COMPLETED
#> 243                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       NOT COMPLETED
#> 244                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P1
#> 245                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  P2
#> 246                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 317
#> 247                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 321
#> 248                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     The 4 participants who were not treated either died (3) or withdrew before treatment start (1).
#> 249                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                The 2 participants who were not treated died before treatment start.
#> 250                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          There were 22 infants that received more doses than intended per protocol.
#>  [ reached 'max' / getOption("max.print") -- omitted 92 rows ]