Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Human milk.
- Who it may be relevant to
- Registry conditions: Prematurity. Basic parameters: 6 Hours — 4 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Overview
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
Interventions
- Dietary supplement Human milk
maternal breastmilk or donor breastmilk
Primary outcome measures
- 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]
Secondary outcome measures (12)
- Body fat percentage [Time frame: Birth to 36 weeks postmenstrual age]
- Anthropometric Measurements [Time frame: Birth to 36 weeks postmenstrual age]
- Bronchopulmonary Dysplasia [Time frame: 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 frame: Birth to 28 days]
- Duration of Hospital Stay in Days [Time frame: Birth to 120 days or discharge, whichever occurs first]
- Growth Rate [Time frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).]
- Number of Participants with Postnatal Faltering Growth [Time frame: 36 weeks or hospital discharge (whichever occurs first)]
- Number of Participants diagnosed with Necrotizing Enterocolitis [Time frame: From birth up to 120 days following birth]
- Number of Participants with Diagnosis of Intestinal Perforation [Time frame: From birth up to 120 days following birth]
- Death [Time frame: Birth to 120 days]
- Culture-proven Sepsis [Time frame: Birth to 120 days]
- Fat Mass (FM)- For age Z-score [Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Alabama at Birmingham — Birmingham
- University of Mississippi Medical Center — Jackson
- University of Texas Southwestern Medical Center at Dallas — Dallas
- University of Texas Health Science Center at Houston — Houston
Identifiers
NCT: NCT06420531 · IRB-300013026 · R01HD117932