Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Running, not enrolling · Not applicable

Conditions studied: Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure, Microbial Colonization

In brief

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.

Key facts

Study ID

NCT04325308

Run by

University of Alabama at Birmingham

People needed

150

Starts

2020-08-13

Expected to finish

2027-09-30

Last updated by the study team

2026-06-29

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age ≤ 28 weeks of gestation
• Postnatal age < 96 hours

You may not qualify if…

• Congenital malformations
• Chromosomal anomalies
• Terminal illness needing to limit or withhold support

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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