Health Trials

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

ConditionsExtreme PrematurityEnteral NutritionBronchopulmonary Dysplasia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity of Alabama at Birmingham

About this trial

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).

Eligibility criteria

Qualifiers

Gestational age ≤ 28 weeks of gestation

Postnatal age < 72 hours

Disqualifiers

Congenital malformations

Chromosomal anomalies

Terminal illness needing to limit or withhold support

Trial design

Treatments tested in this trial

  • High-energy group
  • Standard-energy group

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov