High-energy Human Milk Diets in the First Two Weeks After Birth to Reduce BPD in Extremely Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-energy group, Standard-energy group.
- Who it may be relevant to
- Registry conditions: Extreme Prematurity, Enteral Nutrition, Bronchopulmonary Dysplasia. Basic parameters: 1 Day — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Improving Lung Health in Premature Babies Through Early Nutrition: The More & Early Nutritional Delivery for Bronchopulmonary Dysplasia (MEND-BPD) Trial
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).
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.
Interventions
- Dietary supplement High-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. - Other Standard-energy group
Study participants assigned to the intervention group will receive a standard, fortified human milk diet during the first 2 weeks after birth.
Primary outcome measures
- Severity of respiratory morbidity [Time frame: 0 - 120 days]
- Non-invasive impulse oscillometry measurements of pulmonary mechanics [Time frame: 40 - 120 days]
Secondary outcome measures (1)
- Bronchopulmonary dysplasia [Time frame: 40 - 120 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07307612 · IRB-300016002 · R34HL183268