NCT07307612

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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).

Detailed description

This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a docosahexaenoic acid/arachidonic acid (DHA/ARA)-enriched, fortified human milk diet (intervention group) or a standard fortified human milk diet (control group) during the first 14 days after birth.

Conditions

• Extreme Prematurity
• Enteral Nutrition
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-31
• Primary completion: 2029-03-31
• Completion: 2029-07-31
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States