CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 150 enrolled / 150 target
Drug / intervention
Protein-enriched human milk diet +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04325308
NCT04325308N/AActiveUpdate Overdue (2.1/mo)Completion was 41mo ago
CompareCT.gov

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

University of Alabama at Birmingham·interventional·Posted Mar 27, 2020·Updated Jun 29, 2026

In Brief

A clinical study evaluating Protein-enriched human milk diet and Usual human milk diet for Prematurity; Extreme and 4 related conditions. Active but no longer recruiting, targeting 150 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure, Microbial Colonization
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/AActive
2021202220232024202520262027
First PostedMar 27, 2020
Enrollment StartAug 13, 2020
Primary CompletionJan 2, 2023
Study CompletionSep 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.3 years ago

Arms & Interventions

Protein-enriched human milk dietexperimental

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Procedure: Protein-enriched human milk diet
Usual human milk dietactive_comparator

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Procedure: Usual human milk diet

Interventions

Protein-enriched human milk dietprocedure

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

Usual human milk dietprocedure

Human-based protein will not be added to the human milk administered.