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NOT YET RECRUITING
NCT07307612
PHASE1/PHASE2

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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).

Official title: Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial

Key Details

Gender

All

Age Range

1 Day - 3 Days

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-05-31

Completion Date

2029-07-31

Last Updated

2025-12-29

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States