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

Phase 2Not Yet RecruitingNCT07307612

University of Alabama at Birmingham150 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Extreme Prematurity Enteral Nutrition Bronchopulmonary Dysplasia

Interventions

High-energy groupDIETARY_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 groupOTHER

Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 Days

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 40 - 120 days

Secondary Outcomes

Bronchopulmonary dysplasia

Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age

Time frame: 40 - 120 days

Central Contacts

Ariel A. Salas, MD, MSPH

CONTACT

205-934-4680 asalas@uabmc.edu

Data from ClinicalTrials.gov

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