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

Not Applicable

Active, not recruiting

• Conditions: Enteral Feeding Intolerance; Prematurity; Light-For-Dates
• Interventions: Dietary Supplement: Early HMF; Dietary Supplement: Delayed HMF

• Registration Number: NCT05525585
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Study Start: 2022-11-17
• Primary Completion: 2023-11-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early human milk fortification (HMF) group	Early HMF	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.
Delayed human milk fortification (HMF) group	Delayed HMF	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.

Primary Outcome Measures

Name	Time	Method
Fat-free mass(FFM)-for-age Z-score	Postnatal day 14 to 21	Estimated by air displacement plethysmography

Secondary Outcome Measures

Name	Time	Method
Fecal microbiome composition	Birth to 36 weeks postmenstrual age	Determined by 16S RNA sequencing of bacteria in stool samples
Duration of hospital stay in days	Birth to 60 days or discharge, whichever occurs first	From day of admission to day of hospital discharge to home
Growth - Weight	Birth to 36 weeks postmenstrual age or hospital discharge	Measured weekly in grams and z scores as part of routine care
Growth - Length	Birth to 36 weeks postmenstrual age or hospital discharge	Measured weekly in cm and z scores as part of routine care
Growth - Head circumference	Birth to 36 weeks postmenstrual age or hospital discharge	Measured weekly in cm and z scores as part of routine care
Growth rate	Birth to 36 weeks postmenstrual age or hospital discharge	Weight gain in g/kg/day
Number of participants with diagnosis of intestinal perforation	Birth to 10 days	Diagnosis of intestinal perforation
Death	Birth to 60 days	Death prior to postnatal day 60
Number of participants with postnatal growth faltering	Birth to 36 weeks postmenstrual age or hospital discharge	Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2
Number of participants with diagnosis of necrotizing enterocolitis	Birth to 60 days or discharge	Diagnosis of necrotizing enterocolitis stage 2 or 3

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States