PrematurityMAGICNCT06420531
Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
A study testing Human milk in people with Prematurity, run by University of Alabama at Birmingham at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 hours to 4 days
- Conditions the study is for
- Prematurity
- What is being tested?
- Human milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Sep 2025to 30 Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 hours to 4 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Ariel A. Salas, MD, MSPH, 205-934-4680, asalas@uab.edu
- Recruiting
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Eric Ortigoza, MD, MSCR, 214-648-3903, Eric.Ortigoza@UTSouthwestern.edu
Eric Ortigoza, MD, MSCR
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Mar Romero-Lopez, MD, PhD, 713-500-7283, Maria.del.Mar.RomeroLopez@uth.tmc.edu
Mar Romero-Lopez, MD, PhD
- Not yet recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Simon Karam, MD, 601-815-3464, skaram@umc.edu
Simon Karam, MD
About this study
Official title: 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.
Read the 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
- Conditions
- Prematurity
- Being tested
- Human milk
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human milkDietary supplement
maternal breastmilk or donor breastmilk
| Study group | Role | What they receive |
|---|---|---|
| Intervention: 180-200 mL/kg/day of human milk | Experimental | Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age. Receives: Dietary Supplement: Human milk |
| Control:140-160 mL/kg/day of human milk | Placebo comparator | Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age. Receives: Dietary Supplement: Human milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Secondary outcomes (15)
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.
Measured: Birth to 36 weeks postmenstrual age
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).
Measured: Birth to 36 weeks postmenstrual age
Bronchopulmonary Dysplasia
Number of participants receiving supplemental oxygen at 36 weeks (PMA)
Measured: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Number of Days Alive and Receiving Full Enteral Feeding
Time to full enteral feeding days
Measured: Birth to 28 days
Duration of Hospital Stay in Days
From day of admission to day of hospital discharge to home
Measured: Birth to 120 days or discharge, whichever occurs first
Growth Rate
Weight gain in g/kg/day
Measured: 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.
Measured: 36 weeks or hospital discharge (whichever occurs first)
Number of Participants diagnosed with Necrotizing Enterocolitis
Diagnosis of necrotizing enterocolitis stage 2 or 3
Measured: From birth up to 120 days following birth
Number of Participants with Diagnosis of Intestinal Perforation
Diagnosis of intestinal perforation
Measured: From birth up to 120 days following birth
Death
Death prior to 121 days of life
Measured: Birth to 120 days
Culture-proven Sepsis
Diagnosis of sepsis with positive blood cultures
Measured: Birth to 120 days
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.
Measured: 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.
Measured: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Duration of parenteral nutrition
Number of days receiving parenteral nutrition
Measured: Birth to 28 days of life
Post discharge growth outcomes
Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.
Measured: 22-26 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start16 Sep 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Ariel A. Salas, MD, MSPH, Principal investigator, UAB Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420531
- Sponsor's protocol ID
- IRB-300013026
- Other IDs
- R01HD117932
- Acronym
- MAGIC
- Status last verified
- Jun 2026
- First submitted
- 14 May 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No