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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

NCT05525585

Active Not RecruitingNA

Sponsor: University of Alabama at Birmingham

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

Interventions: Early HMF, Delayed HMF

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 1 Day to 4 Days

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

* Small for gestational age (\<5th percentile)
* Major congenital/chromosomal anomalies
* Terminal illness needing withhold or limit support
Locations (1)
  • Birmingham, Alabama, United States