Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
University of Alabama at Birmingham
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).
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.
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- Dietary SupplementHigh-energy group
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.
- OtherStandard-energy group
Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
Location
- University of Alabama at BirminghamBirmingham, Alabama