Human milk
Dietary Supplementmaternal breastmilk or donor breastmilk
NCT Number: NCT06420531
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.
Interested in participating?
Request Info6 hour–4 day
All sexes
Interventional
Not applicable
University of Alabama at Birmingham, Birmingham, Alabama, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
maternal breastmilk or donor breastmilk
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
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.
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).
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)
Time frame: Birth to 28 days
Time to full enteral feeding days
Time frame: Birth to 120 days or discharge, whichever occurs first
From day of admission to day of hospital discharge to home
Time frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
Weight gain in g/kg/day
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.
Time frame: From birth up to 120 days following birth
Diagnosis of necrotizing enterocolitis stage 2 or 3
Time frame: From birth up to 120 days following birth
Diagnosis of intestinal perforation
Time frame: Birth to 120 days
Death prior to 121 days of life
Time frame: Birth to 120 days
Diagnosis of sepsis with positive blood cultures
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.
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.
Time frame: Birth to 28 days of life
Number of days receiving parenteral nutrition
Time frame: 22-26 months corrected age
Weight, length, and head circumference measurements. Measurements will be converted into Z-scores.
Time frame: Birth to 36 weeks postmenstrual age
Determined by molecular analyses of fecal samples
Time frame: 36 weeks postmenstrual age or discharge (whichever occurs first)
Determined by molecular analyses of serum samples
Time frame: 2 - 3 years of age
Neurodevelopmental outcomes measured by voluntary PARCA-R survey
Contact information is provided by the study sponsor or research team.
University of Alabama at Birmingham
Other
A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Acronym: MAGIC
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.
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