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ACTIVE NOT RECRUITING
NCT04325308
NA

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Protein-enriched human milk diet

1.2 g of human-based protein will be added to each 100 ml of human milk administered

PROCEDURE

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