Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06420531

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 hour–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human milk

Dietary Supplement

maternal breastmilk or donor breastmilk

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Body fat percentage

    Time frame: Birth to 36 weeks postmenstrual age

    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.

  2. Anthropometric Measurements

    Time frame: Birth to 36 weeks postmenstrual age

    Weight, length, head circumference, and mid-upper arm circumference measurements. Measurements will be converted into Z-scores based on Fenton growth curves (2013).

  3. Bronchopulmonary Dysplasia

    Time frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

    Number of participants receiving supplemental oxygen at 36 weeks (PMA)

  4. Number of Days Alive and Receiving Full Enteral Feeding

    Time frame: Birth to 28 days

    Time to full enteral feeding days

  5. Duration of Hospital Stay in Days

    Time frame: Birth to 120 days or discharge, whichever occurs first

    From day of admission to day of hospital discharge to home

  6. Growth Rate

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).

    Weight gain in g/kg/day

  7. Number of Participants with Postnatal Faltering Growth

    Time frame: 36 weeks or hospital discharge (whichever occurs first)

    Diagnosis of faltering growth (weight z score decline from birth to 36 weeks > 1) using the 2013 Fenton growth curve.

  8. Number of Participants diagnosed with Necrotizing Enterocolitis

    Time frame: From birth up to 120 days following birth

    Diagnosis of necrotizing enterocolitis stage 2 or 3

  9. Number of Participants with Diagnosis of Intestinal Perforation

    Time frame: From birth up to 120 days following birth

    Diagnosis of intestinal perforation

  10. Death

    Time frame: Birth to 120 days

    Death prior to 121 days of life

  11. Culture-proven Sepsis

    Time frame: Birth to 120 days

    Diagnosis of sepsis with positive blood cultures

  12. Fat Mass (FM)- For age Z-score

    Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer

    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.

  13. Body Fat (BF)-For age Z-score

    Time frame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

    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.

  14. Duration of parenteral nutrition

    Time frame: Birth to 28 days of life

    Number of days receiving parenteral nutrition

  15. Post discharge growth outcomes

    Time frame: 22-26 months corrected age

    Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.

Other outcomes

  1. Changes in Intestinal Microbiome

    Time frame: Birth to 36 weeks postmenstrual age

    Determined by molecular analyses of fecal samples

  2. Changes in Metabolic Pathways

    Time frame: 36 weeks postmenstrual age or discharge (whichever occurs first)

    Determined by molecular analyses of serum samples

  3. Cognitive scores

    Time frame: 2 - 3 years of age

    Neurodevelopmental outcomes measured by voluntary PARCA-R survey

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel A. Salas, MD, MSPH

CONTACT

[email protected]

205-934-4680

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: MAGIC

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
May 20, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.