Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
ConditionPrematurity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-4
SponsorUniversity of Alabama at Birmingham
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Necrotizing enterocolitis stage 2 or greater
Spontaneous intestinal perforation
Major congenital/chromosomal anomalies
Terminal illness requiring limited or withheld support
Trial design
Design model
Parallel
Treatments tested in this trial
Human milk
Dietary supplementmaternal breastmilk or donor breastmilk
Treatment groups
486 Participants
are divided into 2 treatment groupsGroup A: Intervention: 180-200 mL/kg/day of human milkExperimental treatment 1 intervention
Group B: Control:140-160 mL/kg/day of human milkPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longerSecondary outcomes
1
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.
Time frame
Birth to 36 weeks postmenstrual age2
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).
Time frame
Birth to 36 weeks postmenstrual age3
Bronchopulmonary Dysplasia
Number of participants receiving supplemental oxygen at 36 weeks (PMA)
Time frame
36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer4
Number of Days Alive and Receiving Full Enteral Feeding
Time to full enteral feeding days
Time frame
Birth to 28 daysOther outcomes
1
Changes in Intestinal Microbiome
Determined by molecular analyses of fecal samples
Time frame
Birth to 36 weeks postmenstrual age2
Changes in Metabolic Pathways
Determined by molecular analyses of serum samples
Time frame
36 weeks postmenstrual age or discharge (whichever occurs first)3
Cognitive scores
Neurodevelopmental outcomes measured by voluntary PARCA-R survey
Time frame
2 - 3 years of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov