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High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants

NCT07307612 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-29

No results posted yet for this study

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

Interventions

OTHER

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ariel A. Salas, MD, MSPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-03-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307612 on ClinicalTrials.gov