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

N/AActive Not RecruitingNCT05525585

University of Alabama at Birmingham80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Prematurity Light-For-Dates Enteral Feeding Intolerance

Interventions

Early HMFDIETARY_SUPPLEMENT

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

Delayed HMFDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 4 Days

Medical Language ↔ Plain English

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)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Fat-free mass(FFM)-for-age Z-score

Estimated by air displacement plethysmography

Time frame: Postnatal day 14 to 21

Secondary Outcomes

Fecal microbiome composition

Determined by 16S RNA sequencing of bacteria in stool samples

Time frame: Birth to 36 weeks postmenstrual age

Growth - Weight

Measured weekly in grams and z scores as part of routine care