A Phase 3 interventional study of Active Treatment and Expectant Management in Infant, Premature, Patent Ductus Arteriosus and Infant, Newborn, Diseases, sponsored by NICHD Neonatal Research Network. Active, not recruiting at 19 sites in United States. Open to participants aged 48 Hours to 21 Days. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by NICHD Neonatal Research Network · Phase 3, Interventional, and Treatment
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Among 41 studies in Premature Birth by NICHD Neonatal Research Network — 2 open to participants now, 5 under way, 2 of them phase 3. Premature Birth · NICHD Neonatal Research Network.
Among the 41 studies in Premature Birth by NICHD Neonatal Research Network, this one is the 17th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2019, is one of 13 in phase 3, and was the 39th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →2 of the 41 studies in Premature Birth by NICHD Neonatal Research Network are open now, in 1 country. Recruiting first, the newest first:
NICHD Neonatal Research Network · Sites in United States
Ages 18 mo–26 mo
NICHD Neonatal Research Network · Sites in United States
Ages up to 14 days
By country, each count listing its studies:
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 48 Hours to 21 Days · all sexes · no healthy volunteers.
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41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 10 · Phase 3 17
First in 1987; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 482 is above the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Median enrollment 570 across the 28 interventional studies, 1,067 across the 13 observational. Of the 36 that completed or were terminated, 7 (19%) have results posted.
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NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 41 studies in Premature Birth by NICHD Neonatal Research Network, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in premature infants with a sPDA, expectant management reduces the incidence proportion of death or BPD by 10% (from 50% to 40%) when compared to active treatment.
Participants with a sPDA allocated to the active treatment arm will receive intravenous administration of indomethacin or ibuprofen (depending on center preference). The decision to ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant management arm will receive supportive care at the clinical team's discretion and will receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise. The decision to ligate will be left to the clinical team.
The primary endpoint for the study will be death or BPD (as assessed by the physiologic definition) at 36 weeks postmenstrual age (PMA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
sPDA, as defined as:
Exclusion Criteria:
Infants assigned to the active treatment group will receive indomethacin or ibuprofen 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.
Other: Active Treatment
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
Other: Expectant Management
Infants assigned to the active treatment group will receive indomethacin or ibuprofen 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. If the infant receives both, it will be considered a protocol violation.
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA
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.
Time frame: Randomization to 36 weeks PMA
Mortality at 36 Weeks PMA
mortality assessed at 36 week postmenstrual age
Time frame: birth to 36 week postmenstrual age
Mortality Before Discharge
mortality assessed prior to hospital discharge
Time frame: birth to 120 days of life
Bronchopulmonary Dysplasia - Physiological Test
BPD defined by the physiologic test of oxygen therapy
Time frame: birth to 36 week postmenstrual age
Bronchopulmonary Dysplasia - NIH Consensus Definition
BPD defined by the NIH consensus definition of moderate or severe
Time frame: birth to 36 week postmenstrual age
Necrotizing Enterocolitis (NEC) at 36 Weeks PMA
Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Time frame: birth to 36 weeks post menstrual age
Retinopathy of Prematurity at 36 Weeks PMA
Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Time frame: birth to 36 weeks post menstrual age
Receipt of Therapies Designed to Close the PDA
Defined as ligation or cardiac catheterization
Time frame: birth to 120 days
Weight at 36 Weeks PMA
Weight assessed at 36 weeks post menstrual age
Time frame: birth to 36 weeks post menstrual age
Height at 36 Weeks PMA
Height assessed at 36 weeks post menstrual age
Time frame: birth to 36 weeks post menstrual age
Head Circumference at 36 Weeks PMA
Head Circumference assessed at 36 weeks post menstrual age
Time frame: birth to 36 weeks post menstrual age
Necrotizing Enterocolitis (NEC) at Status (2 Years)
Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Time frame: 26 months corrected age
Retinopathy of Prematurity at Status (2 Years)
Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Time frame: 26 months corrected age
Weight at Status (2 Years)
Weight assessed at status (2 years)
Time frame: 26 months corrected age
Height at Status (2 Years)
Height assessed at status (2 years)
Time frame: 26 months corrected age
Head Circumference at Status (2 Years)
Head Circumference assessed at status (2 years)
Time frame: 26 months corrected age
Neurodevelopmental Impairment (NDI) at Status (2 Years)
Severe 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.
Time frame: 26 months corrected age
| Milestone | Active Treatment Group | Expectant Management Group |
|---|---|---|
| Started | 240 | 242 |
| Completed | 213 | 223 |
| Not completed | 27 | 19 |
| Withdrew: Death | 23 | 10 |
| Withdrew: Withdrawal by subject | 4 | 8 |
| Withdrew: Withdrew consent for any use of data | 0 | 1 |
mortality assessed at 36 week postmenstrual age
Results for this outcome have not been posted.
mortality assessed prior to hospital discharge
Results for this outcome have not been posted.
BPD defined by the physiologic test of oxygen therapy
Results for this outcome have not been posted.
BPD defined by the NIH consensus definition of moderate or severe
Results for this outcome have not been posted.
Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Results for this outcome have not been posted.
Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Results for this outcome have not been posted.
Defined as ligation or cardiac catheterization
Results for this outcome have not been posted.
Weight assessed at 36 weeks post menstrual age
Results for this outcome have not been posted.
Proven NEC, no surgery, Stages IIA, IIB, or IIIA AND proven, surgery, Stage IIIB
Results for this outcome have not been posted.
Stage 3 or worse in either eye AND as any intervention therapy-retinal ablation, scleral buckle/vitrectomy, avastin or other anti-VEGF drug
Results for this outcome have not been posted.
Weight assessed at status (2 years)
Results for this outcome have not been posted.
Height assessed at status (2 years)
Results for this outcome have not been posted.
Head Circumference assessed at status (2 years)
Results for this outcome have not been posted.
Severe 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.
Results for this outcome have not been posted.
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.
| Participants | Active Treatment Group | Expectant Management Group |
|---|---|---|
| Yes | 191 | 195 |
| No | 49 | 46 |
Height assessed at 36 weeks post menstrual age
Results for this outcome have not been posted.
Head Circumference assessed at 36 weeks post menstrual age
Results for this outcome have not been posted.
Collected over Adverse events are reported from time of randomization to 36 completed weeks PMA.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment Group | 23/240 (9.6%) | 43/240 (17.9%) | 3/240 (1.3%) |
| Expectant Management Group | 10/241 (4.1%) | 32/241 (13.3%) | 9/241 (3.7%) |
| Event | Active Treatment Group | Expectant Management Group |
|---|---|---|
| Necrotising enterocolitis neonatalGastrointestinal disorders | 19/240 | 17/241 |
| Sepsis neonatalInfections and infestations | 6/240 | 4/241 |
| Septic shockInfections and infestations | 3/240 | 0/241 |
| Renal failureRenal and urinary disorders | 3/240 | 0/241 |
| Neonatal respiratory failureRespiratory, thoracic and mediastinal disorders | 0/240 | 3/241 |
| Neonatal intestinal perforationGastrointestinal disorders | 2/240 | 1/241 |
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 1/240 | 2/241 |
| Pneumonia escherichiaInfections and infestations | 1/240 | 0/241 |
| Enterobacter pneumoniaInfections and infestations | 1/240 | 0/241 |
| Staphylococcal sepsisInfections and infestations | 1/240 | 0/241 |
| Event | Active Treatment Group | Expectant Management Group |
|---|---|---|
| Necrotising enterocolitis neonatalGastrointestinal disorders | 1/240 | 4/241 |
| Renal failureRenal and urinary disorders | 0/240 | 2/241 |
| Pulmonary haemorrhage neonatalRespiratory, thoracic and mediastinal disorders | 1/240 | 0/241 |
| Splenic infarctionBlood and lymphatic system disorders | 1/240 | 0/241 |
| Neonatal pneumoniaInfections and infestations | 0/240 | 1/241 |
| Neonatal sinus bradycardiaCardiac disorders | 0/240 | 1/241 |
| Neonatal hypotensionVascular disorders | 0/240 | 1/241 |
One infant was randomized but withdrew consent for use of any data. This infant is excluded from all analyses.
| Age, Continuous(Weeks) | Active Treatment Group | Expectant Management Group | Total |
|---|---|---|---|
| Median | 25.6 (24.3 to 27.3) | 25.6 (24.6 to 27.0) | 25.6 (24.4 to 27.1) |
| Sex: Female, Male(Participants) | Active Treatment Group | Expectant Management Group | Total |
|---|---|---|---|
| Female | 117 | 120 | 237 |
| Male | 123 | 121 | 244 |
| Race (NIH/OMB)(Participants) | Active Treatment Group | Expectant Management Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 7 | 9 | 16 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Black or African American | 82 | 93 | 175 |
| White | 120 | 112 | 232 |
| More than one race | 5 | 7 | 12 |
| Unknown or Not Reported | 24 | 18 | 42 |
| Ethnicity (NIH/OMB)(Participants) | Active Treatment Group | Expectant Management Group | Total |
|---|---|---|---|
| Hispanic or Latino | 58 | 55 | 113 |
| Not Hispanic or Latino | 182 | 186 | 368 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Per NIH Data Sharing Plan
Supporting information: Study protocol, Statistical analysis plan
Ran from Feb 2019 to primary completion in Mar 2025, 72 months.
Results were first posted in May 2026, 1 year 2 months after primary completion.
Of 35 non-industry phase 3 interventional studies under Premature Birth, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 89. This study's 72 months is above that.
Counting every sponsor, half of 40 studies reached it within 51 months; a quarter within 28 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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NICHD Neonatal Research Network