Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
- Conditions
- Prematurity
- Interventions
- Biological: Human milk
- Registration Number
- NCT06420531
- Lead Sponsor
- University of Alabama at Birmingham
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 486
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention: 180-200 mL/kg/day of human milk Human milk Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age. Control:140-160 mL/kg/day of human milk 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 Measures
Name Time Method Fat-free Mass (FFM)-For-age-Z-score 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 Outcome Measures
Name Time Method Body fat percentage 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.
Anthropometric Measurements 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).
Number of Participants with Postnatal Faltering Growth 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.
Death Birth to 120 days Death prior to 121 days of life
Culture-proven Sepsis Birth to 120 days Diagnosis of sepsis with positive blood cultures
Post discharge growth outcomes 22-26 months corrected age Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.
Body Fat (BF)-For age Z-score 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.
Number of Days Alive and Receiving Full Enteral Feeding Birth to 28 days Time to full enteral feeding days
Duration of Hospital Stay in Days Birth to 120 days or discharge, whichever occurs first From day of admission to day of hospital discharge to home
Fat Mass (FM)- For age Z-score 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.
Duration of parenteral nutrition Birth to 28 days of life Number of days receiving parenteral nutrition
Bronchopulmonary Dysplasia 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)
Growth Rate Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first). Weight gain in g/kg/day
Number of Participants diagnosed with Necrotizing Enterocolitis From birth up to 120 days following birth Diagnosis of necrotizing enterocolitis stage 2 or 3
Number of Participants with Diagnosis of Intestinal Perforation From birth up to 120 days following birth Diagnosis of intestinal perforation
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States