Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

NCT ID: NCT04325308

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2026-09-30

Brief 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.

Detailed Description

Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Protein-enriched human milk diet

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

Group Type: EXPERIMENTAL

Protein-enriched human milk diet

Intervention Type: PROCEDURE

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

Usual human milk diet

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

Group Type: ACTIVE_COMPARATOR

Usual human milk diet

Intervention Type: PROCEDURE

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

Interventions

Protein-enriched human milk diet

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

Intervention Type: PROCEDURE

Usual human milk diet

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ariel A. Salas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel Salas, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Tucker MJ, Jeffcoat SH, Argent T, Travers CP, Salas AA. Severity of Bronchopulmonary Dysplasia in Infants Born Extremely Preterm and Randomized to Early Human Milk Fortification with a Donor Milk-Derived Fortifier for 2 Weeks. J Pediatr. 2025 Jul 24;287:114750. doi: 10.1016/j.jpeds.2025.114750. Online ahead of print.

Reference Type: RESULT

PMID: 40714049 (View on PubMed)

Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603.

Reference Type: RESULT

PMID: 37551512 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23HD102554

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300005089

Identifier Type: -

Identifier Source: org_study_id