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

Running, not enrolling · Not applicable

Conditions studied: Prematurity, Light-For-Dates, Enteral Feeding Intolerance

In brief

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.

Key facts

Study ID

NCT05525585

Run by

University of Alabama at Birmingham

People needed

80

Starts

2022-11-17

Expected to finish

2027-05-01

Last updated by the study team

2026-06-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.