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

NCT07307612 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IRB-300016002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Extreme Prematurity; Enteral Nutrition; Bronchopulmonary Dysplasia

Keywords

Prematurity; Extreme

Outcome Measures

Primary Outcomes (2)

• Severity of respiratory morbidity

  A scoring system that defines severity of respiratory morbidity (bronchopulmonary dysplasia severity) based on the amount of ventilatory support and the need for supplemental oxygen at 36 weeks postmenstrual age using the Jensen criteria, an ordinal scale ranging from 0 (no respiratory support) to 1 (mild BPD: low-flow nasal cannula ≤2 L/min requirement); 2 (moderate BPD: non-invasive respiratory support, including high-flow nasal cannula \>2 L/min, CPAP, or non-invasive positive pressure ventilation); 3 (severe BPD - invasive mechanical ventilation); or 4 (death), with progressively higher scores indicating increasing respiratory morbidity and worse clinical outcomes.

  0 - 120 days

• Non-invasive impulse oscillometry measurements of pulmonary mechanics

  Using the N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)

  40 - 120 days

Secondary Outcomes (1)

• Bronchopulmonary dysplasia

  40 - 120 days

Study Arms (2)

High-energy Group

ACTIVE COMPARATOR

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.

Dietary Supplement: High-energy group

Standard-energy Group

OTHER

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

Other: Standard-energy group

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.

High-energy Group

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.

Standard-energy Group

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≤ 28 weeks of gestation
• Postnatal age \< 72 hours

You may not qualify if:

• Congenital malformations
• Chromosomal anomalies
• Terminal illness needing to limit or withhold support

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ariel A. Salas, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel A. Salas, MD, MSPH

CONTACT

205-934-4680; asalas@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To maintain trial integrity, nutrition room staff that are independent of clinical care will prepare the feeding syringes without DHA/ARA labels to ensure clinicians, parents, and evaluators remain masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Following written informed consent, participants are assigned in a 2:1 ratio to either the intervention (supplementation) or control (standard diet) group.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: December 29, 2025
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (1)