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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06420531
Status
Recruiting
Apply to this trial

Conditions

  • Prematurity

Eligibility Criteria

Sex
ALL
Age
6 Hours - 4 Days
Healthy Volunteers
Not accepted

Interventions

  • Human milk — DIETARY_SUPPLEMENT
    maternal breastmilk or donor breastmilk

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
Sep 2025
Primary completion
Jan 1, 2029
Completion
Aug 30, 2030

Study Design

Enrollment
486 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Ariel A. Salas, MD, MSPH
[email protected]
205-934-4680
University of Mississippi Medical CenterJacksonMississippi39216
Simon Karam, MD
[email protected]
601-815-3464
Simon Karam, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center at DallasDallasTexas75235
Eric Ortigoza, MD, MSCR
[email protected]
214-648-3903
Eric Ortigoza, MD, MSCR (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77030
Mar Romero-Lopez, MD, PhD
[email protected]
713-500-7283
Mar Romero-Lopez, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Mississippi Medical Center· Jackson, MSUniversity of Texas Southwestern Medical Center at Dallas· Dallas, TXUniversity of Texas Health Science Center at Houston· Houston, TX

Related Studies