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).
Gestational age ≤ 28 weeks of gestation
Postnatal age < 72 hours
Congenital malformations
Chromosomal anomalies
Terminal illness needing to limit or withhold support
Parallel
High-energy group
Dietary supplementStudy 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 interventionStudy participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
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.
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)
Bronchopulmonary dysplasia
Defined as the need for ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age
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University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
