RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09-16
Study Completion:2030-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06420531

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.

Ages Eligible for Study:6 Hours to 4 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Gestational age between 27 0/7 and 31 6/7 weeks
  2. * Birthweight of 1500 grams or less
  3. * Human milk feeding during the first 14 days after birth
  4. * Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth
  1. * Necrotizing enterocolitis stage 2 or greater
  2. * Spontaneous intestinal perforation
  3. * Major congenital/chromosomal anomalies
  4. * Terminal illness requiring limited or withheld support
  5. * Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
  6. * Any formula feeding within the first 14 days after birth

Contacts and Locations

Study Contact

Ariel A. Salas, MD, MSPH
CONTACT
205-934-4680
asalas@uab.edu

Principal Investigator

Ariel A. Salas, MD, MSPH
PRINCIPAL_INVESTIGATOR
UAB Hospital

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-16
Study Completion Date2030-08-30

Study Record Updates

Study Start Date2025-09-16
Study Completion Date2030-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Prematurity