Clinical trial NCT06420531: Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial
Official title: A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 486
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Fat-free Mass (FFM)-For-age-Z-score
timeFrame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
Secondary outcomes:
measure: Body fat percentage
timeFrame: Birth to 36 weeks postmenstrual age
measure: Anthropometric Measurements
timeFrame: Birth to 36 weeks postmenstrual age
measure: Bronchopulmonary Dysplasia
timeFrame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
measure: Number of Days Alive and Receiving Full Enteral Feeding
timeFrame: Birth to 28 days
measure: Duration of Hospital Stay in Days
timeFrame: Birth to 120 days or discharge, whichever occurs first
measure: Growth Rate
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurs first).
measure: Number of Participants with Postnatal Faltering Growth
timeFrame: 36 weeks or hospital discharge (whichever occurs first)
measure: Number of Participants diagnosed with Necrotizing Enterocolitis
timeFrame: From birth up to 120 days following birth
measure: Number of Participants with Diagnosis of Intestinal Perforation
timeFrame: From birth up to 120 days following birth
measure: Death
timeFrame: Birth to 120 days
measure: Culture-proven Sepsis
timeFrame: Birth to 120 days
measure: Fat Mass (FM)- For age Z-score
timeFrame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
measure: Body Fat (BF)-For age Z-score
timeFrame: 36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer
measure: Duration of parenteral nutrition
timeFrame: Birth to 28 days of life
measure: Post discharge growth outcomes
timeFrame: 22-26 months corrected age
Other outcomes:
measure: Changes in Intestinal Microbiome
timeFrame: Birth to 36 weeks postmenstrual age
measure: Changes in Metabolic Pathways
timeFrame: 36 weeks postmenstrual age or discharge (whichever occurs first)
measure: Cognitive scores
timeFrame: 2 - 3 years of age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB Hospital
name: Ariel A. Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: