Recruiting
Phase 1
Phase 2

DHA/ARA-Enhanced Milk

Sponsor:

University of Alabama at Birmingham

Code:

NCT07307612

Conditions

Extreme Prematurity

Enteral Nutrition

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

High-energy group

Standard-energy group

Study Details

Brief summary:

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).

Conditions

Extreme Prematurity

Enteral Nutrition

Bronchopulmonary Dysplasia

Study ID

NCT07307612

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: High-energy Group

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.

other: Standard-energy Group

The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.

Interventions

High-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.

Standard-energy group

Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.

Primary outcome measure

  • Severity of respiratory morbidity [ Time Frame: 0 - 120 days ]
  • Non-invasive impulse oscillometry measurements of pulmonary mechanics [ Time Frame: 40 - 120 days ]

Central Contacts and Locations

Central contacts

Ariel A. Salas, MD, MSPH

205-934-4680asalas@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Ariel A. Salas, MD, MSPH

205-934-4680asalas@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Prematurity; Extreme

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.