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

A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm

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.

Study Overview

• Status: Recruiting
• Conditions: Prematurity
• Intervention / Treatment: Dietary supplement: Human milk

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 486
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariel A. Salas, MD, MSPH; Phone Number: 205-934-4680; Email: asalas@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Ariel A. Salas, MD, MSPH; Phone Number: 205-934-4680; Email: asalas@uab.edu
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Not yet recruiting
      • University of Mississippi Medical Center
      • Principal Investigator: Simon Karam, MD
      • Contact: Simon Karam, MD; Phone Number: 601-815-3464; Email: skaram@umc.edu
  • Texas
    • Dallas, Texas, United States, 75235
      • Not yet recruiting
      • University of Texas Southwestern Medical Center at Dallas
      • Contact: Eric Ortigoza, MD, MSCR; Phone Number: 214-648-3903; Email: Eric.Ortigoza@UTSouthwestern.edu
      • Principal Investigator: Eric Ortigoza, MD, MSCR
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • University of Texas Health Science Center at Houston
      • Contact: Mar Romero-Lopez, MD, PhD; Phone Number: 713-500-7283; Email: Maria.del.Mar.RomeroLopez@uth.tmc.edu
      • Principal Investigator: Mar Romero-Lopez, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Human milk; maternal breastmilk or donor breastmilk
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.	Dietary supplement: Human milk; maternal breastmilk or donor breastmilk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat-free Mass (FFM)-For-age-Z-score	Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death prior to 121 days of life	Birth to 120 days
Culture-proven Sepsis	Diagnosis of sepsis with positive blood cultures	Birth to 120 days
Number of Days Alive and Receiving Full Enteral Feeding	Time to full enteral feeding days	Birth to 28 days
Duration of Hospital Stay in Days	From day of admission to day of hospital discharge to home	Birth to 120 days or discharge, whichever occurs first
Body fat percentage	Estimated by bioelectric impedance analysis. Body fat measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	Birth to 36 weeks postmenstrual age
Bronchopulmonary Dysplasia	Number of participants receiving supplemental oxygen at 36 weeks (PMA)	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Growth Rate	Weight gain in g/kg/day	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
Number of Participants with Postnatal Faltering Growth	Diagnosis of faltering growth (weight z score decline from birth to 36 weeks > 1) using the 2013 Fenton growth curve.	36 weeks or hospital discharge (whichever occurs first)
Number of Participants diagnosed with Necrotizing Enterocolitis	Diagnosis of necrotizing enterocolitis stage 2 or 3	From birth up to 120 days following birth
Number of Participants with Diagnosis of Intestinal Perforation	Diagnosis of intestinal perforation	From birth up to 120 days following birth
Fat Mass (FM)- For age Z-score	Estimated by bioelectric impedance analysis. FM measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Body Fat (BF)-For age Z-score	Estimated by bioelectric impedance analysis. BF measurements will be converted into Z-scores using updated sex-specific reference curves of body composition in preterm infants.	36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Anthropometric Measurements	Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).	Birth to 36 weeks postmenstrual age
Duration of parenteral nutrition	Number of days receiving parenteral nutrition	Birth to 28 days of life
Post discharge growth outcomes	Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.	22-26 months corrected age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intestinal Microbiome	Determined by molecular analyses of fecal samples	Birth to 36 weeks postmenstrual age
Changes in Metabolic Pathways	Determined by molecular analyses of serum samples	36 weeks postmenstrual age or discharge (whichever occurs first)
Cognitive scores	Neurodevelopmental outcomes measured by voluntary PARCA-R survey	2 - 3 years of age

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ariel A. Salas, MD, MSPH, UAB Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): August 30, 2030

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Dairy Products; Milk; Milk, Human
• Other Study ID Numbers: IRB-300013026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No