UAB - Center for Clinical and Translational Science

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

Purpose

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

Eligibility

Eligible Ages: Between 1 Day and 4 Days
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Early human milk fortification (HMF) group	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 Mom's milk or donor milk will be fortified between postnatal day 4 and 7
Active Comparator Delayed human milk fortification (HMF) group	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 Mom's milk or donor milk will be fortified between postnatal day 10 and 14

More Details

Status: Active, not recruiting
Sponsor: University of Alabama at Birmingham

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.