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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07307612
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bronchopulmonary Dysplasia
  • Enteral Nutrition
  • Extreme Prematurity

Eligibility Criteria

Sex
ALL
Age
1 Day - 3 Days
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Aug 15, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: High-energy Group
    The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement.
  • Other: Standard-energy Group
    The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.

Primary Outcome Measure

Severity of respiratory morbidity [ Time Frame: 0 - 120 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-

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By research site
University of Alabama at Birmingham· Birmingham, AL

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