RecruitingNot ApplicableNCT06420531

Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm

Sponsor

University of Alabama at Birmingham

Enrollment

486 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Prematurity

Summary

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Eligibility

Min Age: 6 HoursMax Age: 4 Days

Inclusion Criteria4

Gestational age between 27 0/7 and 31 6/7 weeks
Birthweight of 1500 grams or less
Human milk feeding during the first 14 days after birth
Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth

Exclusion Criteria6

Necrotizing enterocolitis stage 2 or greater
Spontaneous intestinal perforation
Major congenital/chromosomal anomalies
Terminal illness requiring limited or withheld support
Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
Any formula feeding within the first 14 days after birth

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