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

NCT05525585 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Early HMF

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

DIETARY_SUPPLEMENT

Delayed HMF

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

Sponsors & Collaborators

  • Mead Johnson Nutrition

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-17
Primary Completion
2023-11-01
Completion
2026-05-31

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 NCT05525585 on ClinicalTrials.gov