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

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

Recruiting
1-3 years
All
Phase 1/2
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Overview

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).

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.

Eligibility

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 details
    Extreme Prematurity
    Enteral Nutrition
    Bronchopulmonary Dysplasia

NCT07307612

University of Alabama at Birmingham

26 September 2026

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