NCT05525585

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

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 4 Days
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-11-17
• Primary completion: 2023-11-01
• Completion: 2026-05-01
• First posted: 2022-09-01
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States