Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
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.
| Condition(s) | Prematurity |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 6 Hours to 4 Days |
| Sex | All |
| Lead sponsor | University of Alabama at Birmingham |
| Locations | Birmingham, Alabama, United States; Jackson, Mississippi, United States; Dallas, Texas, United States; Houston, Texas, United States |
| Start date | 2025-09-16 |
| NCT ID | NCT06420531 |
| Official listing | https://clinicaltrials.gov/study/NCT06420531 |