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Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

NCT04325308 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-23

Study results available
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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.

Conditions

  • Prematurity; Extreme
  • Feeding Disorder Neonatal
  • Breast Milk Expression
  • Growth Failure
  • Microbial Colonization

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ariel Salas, MD, MSPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
4 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2023-01-02
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04325308 on ClinicalTrials.gov