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Recruiting
NCT06420531
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Conditions: Prematurity
Sex: All
Ages: 6 Hours – 4 Days
Healthy volunteers: No
Phase: NA
Enrollment: 486
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
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 Criteria
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
Source: ClinicalTrials.gov (NCT06420531). StuddyBuddy aggregates publicly available trial information.