Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

Description

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.

Conditions

Prematurity

Study Overview

Study Details

Study 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.

A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm

Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

Condition
Prematurity
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

6 Hours to 4 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Ariel A. Salas, MD, MSPH, PRINCIPAL_INVESTIGATOR, UAB Hospital

Study Record Dates

2030-05