A Phase 1/2 interventional study of High-energy group and Standard-energy group in Extreme Prematurity, Enteral Nutrition and Bronchopulmonary Dysplasia, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Prevention
Among 147 studies in Bronchopulmonary Dysplasia with a site in United States — 30 open to participants now, 37 under way, 1 of them phase 3. Bronchopulmonary Dysplasia · United States.
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, this one is the 29th largest by planned enrollment of the 117 interventional ones that give a count, is one of 12 that started in 2026, is one of 10 in phase 1/2, reaches primary completion later than 34 of the 36 other live ones, and was the 140th registered.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
Browse Bronchopulmonary Dysplasia studies →30 of the 147 studies in Bronchopulmonary Dysplasia with a site in United States are open now. Recruiting first, the newest first:
NICHD Neonatal Research Network · Sites in United States
Ages up to 31 wk
University of Alabama at Birmingham · Sites in United States
Ages 7 days–30 days
University of Alabama at Birmingham · Sites in United States
Ages 1 mo–5 mo · Healthy volunteers
Augusta University · Sites in United States
Ages 25 wk–34 wk
Indiana University · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 58 Bronchopulmonary Dysplasia studies recruiting now, 7 (12%) set no upper age limit and 50 (86%) stop at 75 or younger; 56 take children under 18; 11 take healthy volunteers.
This study: 1 Day to 3 Days · all sexes · no healthy volunteers.
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147 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 25 · Phase 2 36 · Phase 3 20 · Phase 4 7
First in 1991; this study’s year is marked. 12 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is above the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Median enrollment 50 across the 117 interventional studies, 155 across the 30 observational. Of the 99 that completed or were terminated, 42 (42%) have results posted.
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11 of 147 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 9 studies filed under Bronchopulmonary Dysplasia — fewer than ten, so there is no comparison to draw.
20 of the studies in Bronchopulmonary Dysplasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT05568264Shirley Ryan AbilityLabEffects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit | 2026-12-31 |
| NCT07447739Khang NguyenCan Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively? | 2027-03 |
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, from their registry updates:
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This Phase II, parallel-group, masked, randomized clinical trial aims to evaluate whether a DHA/ARA-enriched, fortified human milk diet administered during the first 14 days of life reduces respiratory morbidity and improves lung function in extremely preterm (EPT) infants (born at ≤28 weeks gestation).
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.
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.
Exclusion Criteria:
The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement.
Dietary Supplement: High-energy group
The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.
Other: Standard-energy group
Study participants assigned to the intervention group will receive a standard, fortified human milk diet plus a DHA/ARA supplement during the first 2 weeks after birth.
Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
Severity of respiratory morbidity
A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula \>2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes.
Time frame: 0 - 120 days
Non-invasive impulse oscillometry measurements of pulmonary mechanics
Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
Time frame: 40 - 120 days
Bronchopulmonary dysplasia
Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age
Time frame: 40 - 120 days
Started Sep 2026 (actual). Primary completion is estimated for Mar 2029, 30 months after the start.
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