Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

NCT05525585 | Active Not Recruiting DMC

• 2 other identifiers: 300009921000538159
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

Conditions

Prematurity; Light-For-Dates; Enteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

• Fat-free mass(FFM)-for-age Z-score

  Estimated by air displacement plethysmography

  Postnatal day 14 to 21

Secondary Outcomes (10)

• Fecal microbiome composition

  Birth to 36 weeks postmenstrual age

• Growth - Weight

  Birth to 36 weeks postmenstrual age or hospital discharge

• Growth - Length

  Birth to 36 weeks postmenstrual age or hospital discharge

• Growth - Head circumference

  Birth to 36 weeks postmenstrual age or hospital discharge

• Growth rate

  Birth to 36 weeks postmenstrual age or hospital discharge

Study Arms (2)

Early human milk fortification (HMF) group

EXPERIMENTAL

A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.

Dietary Supplement: Early HMF

Delayed human milk fortification (HMF) group

ACTIVE COMPARATOR

A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.

Dietary Supplement: Delayed HMF

Interventions

Early HMF DIETARY_SUPPLEMENT

Mom's milk or donor milk will be fortified between postnatal day 4 and 7

Early human milk fortification (HMF) group

Delayed HMF DIETARY_SUPPLEMENT

Mom's milk or donor milk will be fortified between postnatal day 10 and 14

Delayed human milk fortification (HMF) group

Eligibility Criteria

• Age: 1 Day - 4 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age 29 to 33 weeks of gestation
• Birth weight \< 1800 g
• Postnatal age \< 96 hours

You may not qualify if:

• Small for gestational age (\<5th percentile)
• Major congenital/chromosomal anomalies
• Terminal illness needing withhold or limit support

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Mead Johnson Nutrition: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Salas AA, Gunawan E, Jeffcoat S, Nguyen K. Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial. Am J Clin Nutr. 2025 May;121(5):1117-1123. doi: 10.1016/j.ajcnut.2025.02.019. Epub 2025 Feb 21.

  PMID: 39986385 RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ariel A. Salas, MD, MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: November 17, 2022
• Primary Completion: November 1, 2023
• Study Completion: May 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)