High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies
Official title: Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
Run by University of Alabama at Birmingham · NCT07307612 · Data updated 2026-11-12
This trial tests whether giving DHA/ARA-enriched, fortified human milk in the first 14 days after birth helps extremely preterm infants breathe easier and have better lung function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Status | Recruiting |
| Started | September 21, 2026 |
| Main results expected | March 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07307612 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born at ≤28 weeks gestation who are within 72 hours after birth and fed human milk, without congenital anomalies or terminal illness.
✕Probably not a fit
Some infants may not experience lung benefits from this specific DHA/ARA-enriched diet due to individual variability or other risk factors.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this phase II, parallel-group, masked randomized trial, extremely preterm infants fed human milk are assigned to receive either a DHA/ARA-enriched, fortified diet or a standard fortified human milk diet during the first 14 days of life. The study aims to determine effects on respiratory morbidity and lung function. Participants are enrolled if they are ≤28 weeks gestational age and within 72 hours after birth, excluding those with congenital abnormalities or terminal conditions. The lead sponsor is the University of Alabama at Birmingham, with NHLBI collaboration, and the study is conducted at UAB in Birmingham, AL.
Why it matters
Potential benefit: If successful, the approach could reduce respiratory complications and improve lung outcomes for extremely preterm infants.
How similar studies have gone: Previous work in similar nutrition strategies has shown potential signals, but this exact DHA/ARA-enriched fortification approach in the first two weeks is being tested in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age ≤ 28 weeks of gestation * Postnatal age \< 72 hours Exclusion Criteria: * Congenital malformations * Chromosomal anomalies * Terminal illness needing to limit or withhold support
Where it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting
Study contacts
- Principal investigator: Ariel A. Salas, MD, MSPH — University of Alabama at Birmingham
- Study coordinator: Ariel A. Salas, MD, MSPH
- Email: asalas@uabmc.edu
- Phone: 205-934-4680
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.