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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Prematurity

Treatments: Dietary Supplement: Human milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06420531

IRB-300013026

Details and patient eligibility

About

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.

Full description

Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.

Participants will:

• Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age
• Have four body composition assessments with a bioelectrical impedance analyzer throughout study period
• Have four stool samples collected throughout study period
• Have four maternal breastmilk samples collected and analyzed throughout the study period
• Have one blood sample collected at 36 weeks corrected age
• Have the option to participate in a follow-up survey completed by parents at 2-3 years of age

Enrollment: 486 estimated patients

Sex: All

Ages: 6 hours to 4 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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486 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Dietary Supplement: Human milk

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

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Human milk