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

University of Alabama at Birmingham1 site in 1 country80 target enrollmentNovember 17, 2022

ConditionsPrematurity Light-For-Dates Enteral Feeding Intolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prematurity
Sponsor: University of Alabama at Birmingham
Enrollment: 80
Locations: 1
Primary Endpoint: Fat-free mass(FFM)-for-age Z-score
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 17, 2022

End Date

May 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Ariel A. Salas

Associate Professor of Pediatrics

University of Alabama at Birmingham

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

Outcomes

Primary Outcomes

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

Time Frame: Postnatal day 14 to 21

Estimated by air displacement plethysmography

Secondary Outcomes

Fecal microbiome composition(Birth to 36 weeks postmenstrual age)
Duration of hospital stay in days(Birth to 60 days or discharge, whichever occurs first)
Growth - Weight(Birth to 36 weeks postmenstrual age or hospital discharge)
Growth - Length(Birth to 36 weeks postmenstrual age or hospital discharge)
Growth - Head circumference(Birth to 36 weeks postmenstrual age or hospital discharge)
Growth rate(Birth to 36 weeks postmenstrual age or hospital discharge)
Number of participants with diagnosis of intestinal perforation(Birth to 10 days)
Death(Birth to 60 days)
Number of participants with postnatal growth faltering(Birth to 36 weeks postmenstrual age or hospital discharge)
Number of participants with diagnosis of necrotizing enterocolitis(Birth to 60 days or discharge)