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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07307612

Registry updated: 2026-09-24
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Description

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).

Interventions

  • High-energy group (Dietary supplement)
    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 (Other)
    Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.

Eligibility criteria

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

Conditions

Extreme Prematurity Enteral Nutrition Bronchopulmonary Dysplasia

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record