Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
NCT ID: NCT06420531
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
486 participants
INTERVENTIONAL
2025-09-16
2030-08-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Human milk
maternal breastmilk or donor breastmilk
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.
Human milk
maternal breastmilk or donor breastmilk
Interventions
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Human milk
maternal breastmilk or donor breastmilk
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Hours
4 Days
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Ariel A. Salas
Associate Professor
Principal Investigators
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Ariel A. Salas, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
UAB Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300013026
Identifier Type: -
Identifier Source: org_study_id
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