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

The University of Alabama at Birmingham

Status and phase: Begins enrollment in 4 months; Phase 2; Phase 1

Conditions: Enteral Nutrition; Bronchopulmonary Dysplasia; Extreme Prematurity

Treatments: Other: Standard-energy group; Dietary Supplement: High-energy group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07307612

IRB-300016002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

High-energy Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: High-energy group

Standard-energy Group

Other group

Description:

The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.

Treatment:

Other: Standard-energy group