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Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Sponsor: University of Alabama at Birmingham
Summary
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.
Official title: Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial
Key Details
Gender
All
Age Range
1 Day - 4 Days
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2020-08-13
Completion Date
2026-09-30
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
Protein-enriched human milk diet
1.2 g of human-based protein will be added to each 100 ml of human milk administered
Usual human milk diet
Human-based protein will not be added to the human milk administered.
Locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, United States