Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 1 Day to 3 Days

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.

More Bronchopulmonary Dysplasia trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages1 Day to 3 Days
SexAll
Enrollment150 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Birmingham, Alabama)
StatusRecruiting
StartedSeptember 21, 2026
Main results expectedMarch 31, 2029
Study endsJuly 31, 2029
Registry record updatedSeptember 24, 2026
Trial IDNCT07307612 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

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.