Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Severity of respiratory morbidity
Overview
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).
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 1 Day to 3 Days (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
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
- Bronchopulmonary dysplasia(40 - 120 days)
Investigators
Ariel A. Salas
Associate Professor
University of Alabama at Birmingham