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NCT Number: NCT07307612

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

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).

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Key information

Conditions

Extreme Prematurity Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Enteral Nutrition Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Severity of respiratory morbidity

    Time frame: 0 - 120 days

    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.

  2. Non-invasive impulse oscillometry measurements of pulmonary mechanics

    Time frame: 40 - 120 days

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

Secondary outcomes

  1. Bronchopulmonary dysplasia

    Time frame: 40 - 120 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel A. Salas, MD, MSPH

CONTACT

[email protected]

205-934-4680

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial

Acronym: MEND-BPD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 29, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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