Recruiting

MAGIC

Sponsor:

University of Alabama at Birmingham

Code:

NCT06420531

Conditions

Prematurity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Human milk

Study Details

Brief 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.

Conditions

Prematurity

Study ID

NCT06420531

Start date

Sep 16, 2025

Status verified date

Jun, 2026

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

486 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention: 180-200 mL/kg/day of human milk

Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.

placebo comparator: Control:140-160 mL/kg/day of human milk

Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.

Interventions

Human milk

maternal breastmilk or donor breastmilk

Primary outcome measure

  • Fat-free Mass (FFM)-For-age-Z-score [ Time Frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer ]

Central Contacts and Locations

Central contacts

Ariel A. Salas, MD, MSPH

205-934-4680asalas@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Ariel A. Salas, MD, MSPH

205-934-4680asalas@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-15.