Trial Outcomes & Findings for Management of the PDA Trial (NCT NCT03456336)
NCT ID: NCT03456336
Last Updated: 2026-05-12
Results Overview
A composite outcome for infants who were diagnosed with physiologic bronchopulmonary dysplasia (BPD) or died by 36 weeks postmenstrual age (PMA). Physiologic BPD is determined using existing Neonatal Research Network Generic Database criteria at 36 weeks PMA. Infants alive an in hospital are classified based on respiratory status at 36 weeks PMA or by a room air weaning challenge performed between 36 and 37 weeks PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks PMA.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
482 participants
Primary outcome timeframe
Randomization to 36 weeks PMA
Results posted on
2026-05-12
Participant Flow
One infant was randomized but withdrew consent for use of any data. This infant is included in the Period table below, but excluded from all analyses.
Participant milestones
| Measure |
Active Treatment Group
Infants assigned to the active treatment group will receive indomethacin, ibuprofen or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin, ibuprofen, or acetaminophen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
Infants assigned to the expectant management group will receive indomethacin, ibuprofen, or acetaminophen only if cardiopulmonary compromise occurs.
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
242
|
|
Overall Study
COMPLETED
|
213
|
223
|
|
Overall Study
NOT COMPLETED
|
27
|
19
|
Reasons for withdrawal
| Measure |
Active Treatment Group
Infants assigned to the active treatment group will receive indomethacin, ibuprofen or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin, ibuprofen, or acetaminophen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
Infants assigned to the expectant management group will receive indomethacin, ibuprofen, or acetaminophen only if cardiopulmonary compromise occurs.
|
|---|---|---|
|
Overall Study
Death
|
23
|
10
|
|
Overall Study
Withdrawal by Subject
|
4
|
8
|
|
Overall Study
Withdrew consent for any use of data
|
0
|
1
|
Baseline Characteristics
Gestational age was based on the obstetric estimate (last menstrual period, obstetrical assessments, or early ultrasound). If that was not available or disagreed by more than two weeks with the neonatologist's assessment based on physical or neurologic exams, the neonatologist's estimate was used. If gestational age in days was not recorded, sites entered zero for days.
Baseline characteristics by cohort
| Measure |
Active Treatment Group
n=240 Participants
Infants assigned to the active treatment group will receive indomethacin, ibuprofen, or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin, ibuprofen, or acetaminophen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
n=241 Participants
Infants assigned to the expectant management group will receive indomethacin, ibuprofen, or acetaminophen only if cardiopulmonary compromise occurs.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=1512 Participants
|
9 Participants
n=504 Participants
|
16 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Age, Continuous
|
25.6 Weeks
n=1512 Participants • Gestational age was based on the obstetric estimate (last menstrual period, obstetrical assessments, or early ultrasound). If that was not available or disagreed by more than two weeks with the neonatologist's assessment based on physical or neurologic exams, the neonatologist's estimate was used. If gestational age in days was not recorded, sites entered zero for days.
|
25.6 Weeks
n=504 Participants • Gestational age was based on the obstetric estimate (last menstrual period, obstetrical assessments, or early ultrasound). If that was not available or disagreed by more than two weeks with the neonatologist's assessment based on physical or neurologic exams, the neonatologist's estimate was used. If gestational age in days was not recorded, sites entered zero for days.
|
25.6 Weeks
n=2016 Participants • Gestational age was based on the obstetric estimate (last menstrual period, obstetrical assessments, or early ultrasound). If that was not available or disagreed by more than two weeks with the neonatologist's assessment based on physical or neurologic exams, the neonatologist's estimate was used. If gestational age in days was not recorded, sites entered zero for days.
|
|
Sex: Female, Male
Female
|
117 Participants
n=1512 Participants
|
120 Participants
n=504 Participants
|
237 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=1512 Participants
|
121 Participants
n=504 Participants
|
244 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
82 Participants
n=1512 Participants
|
93 Participants
n=504 Participants
|
175 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=1512 Participants
|
112 Participants
n=504 Participants
|
232 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=1512 Participants
|
7 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
42 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=1512 Participants
|
55 Participants
n=504 Participants
|
113 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
182 Participants
n=1512 Participants
|
186 Participants
n=504 Participants
|
368 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infant participants who were randomized and who provided outcome data.
A composite outcome for infants who were diagnosed with physiologic bronchopulmonary dysplasia (BPD) or died by 36 weeks postmenstrual age (PMA). Physiologic BPD is determined using existing Neonatal Research Network Generic Database criteria at 36 weeks PMA. Infants alive an in hospital are classified based on respiratory status at 36 weeks PMA or by a room air weaning challenge performed between 36 and 37 weeks PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks PMA.
Outcome measures
| Measure |
Active Treatment Group
n=240 Participants
Infants assigned to the active treatment group will receive indomethacin, ibuprofen, or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin, ibuprofen, or acetaminophen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
n=241 Participants
Infants assigned to the expectant management group will receive indomethacin or ibuprofen only if cardiopulmonary compromise occurs.
|
|---|---|---|
|
Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA
Yes
|
191 Participants
|
195 Participants
|
|
Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA
No
|
49 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: birth to 36 week postmenstrual agemortality assessed at 36 week postmenstrual age
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 120 days of lifemortality assessed prior to hospital discharge
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 week postmenstrual ageBPD defined by the physiologic test of oxygen therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 week postmenstrual ageBPD defined by the NIH consensus definition of moderate or severe
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 weeks post menstrual ageProven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 weeks post menstrual ageStage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 120 daysDefined as ligation or cardiac catheterization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 weeks post menstrual ageWeight assessed at 36 weeks post menstrual age
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 weeks post menstrual ageHeight assessed at 36 weeks post menstrual age
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: birth to 36 weeks post menstrual ageHead Circumference assessed at 36 weeks post menstrual age
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageProven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageStage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageWeight assessed at status (2 years)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageHeight assessed at status (2 years)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageHead Circumference assessed at status (2 years)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 months corrected ageSevere NDI will be defined by any of the following: a Bayley Scales of Infant and Toddler Development (BSID) III cognitive score \< 70, Gross Motor Functional (GMF) Level of 3-5, blindness (\<20/200 vision) or profound hearing loss (inability to understand commands despite amplification); moderate NDI will be defined as a BSID III cognitive score 70-84 and either a GMF level of 2 or a hearing deficit requiring amplification to understand commands or unilateral blindness; mild NDI will be defined by a cognitive score 70-84, or a cognitive score ≥ 85 and any of the following: presence of a GMF level 1 or hearing loss not requiring amplification. Normal (no NDI) will be defined by a cognitive score ≥ 85 and absence of any neurosensory deficits.
Outcome measures
Outcome data not reported
Adverse Events
Active Treatment Group
Serious events: 43 serious events
Other events: 3 other events
Deaths: 23 deaths
Expectant Management Group
Serious events: 32 serious events
Other events: 9 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Active Treatment Group
n=240 participants at risk
Infants assigned to the active treatment group will receive indomethacin, ibuprofen, or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
n=241 participants at risk
Infants assigned to the expectant management group will receive indomethacin, ibuprofen, or acetaminophen only if cardiopulmonary compromise occurs.
|
|---|---|---|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
7.9%
19/240 • Number of events 19 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
7.1%
17/241 • Number of events 17 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Sepsis neonatal
|
2.5%
6/240 • Number of events 6 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
1.7%
4/241 • Number of events 4 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Gastrointestinal disorders
Neonatal intestinal perforation
|
0.83%
2/240 • Number of events 2 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Group B streptococcus neonatal sepsis
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Septic shock
|
1.2%
3/240 • Number of events 3 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Pneumonia escherichia
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Fungal sepsis
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
1.2%
3/241 • Number of events 3 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.83%
2/241 • Number of events 2 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pulmonary hypertension
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage neonatal
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Cardio-respiratory arrest neonatal
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pneumothorax
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Cardiac disorders
Cardiac arrest neonatal
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
3/240 • Number of events 3 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Eye disorders
Retinopathy of prematurity
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Hepatobiliary disorders
Hepatic infarction
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
Other adverse events
| Measure |
Active Treatment Group
n=240 participants at risk
Infants assigned to the active treatment group will receive indomethacin, ibuprofen, or acetaminophen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other.
|
Expectant Management Group
n=241 participants at risk
Infants assigned to the expectant management group will receive indomethacin, ibuprofen, or acetaminophen only if cardiopulmonary compromise occurs.
|
|---|---|---|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
1.7%
4/241 • Number of events 4 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage neonatal
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Cardiac disorders
Neonatal sinus bradycardia
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.83%
2/241 • Number of events 3 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.42%
1/240 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.00%
0/241 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
|
Vascular disorders
Neonatal hypotension
|
0.00%
0/240 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
0.41%
1/241 • Number of events 1 • Adverse events are reported from time of randomization to 36 completed weeks PMA.
A serious adverse events is defined as: resulting in death, is life-threatening, requires prolongation of hospitalization, resulting in persistent or significant disability/incapacity, or any other serious important medical events.
|
Additional Information
Matthew Laughon
University of North Carolina at Chapel Hill
Phone: (984) 974-7851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place