ACTIVE_NOT_RECRUITING

Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development

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

This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.

Official Title

Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development

Quick Facts

Study Start:2020-01-31
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03977259

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:1 Day to 21 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Inpatient in Brigham and Women's Hospital NICU
  2. * Gestational age 24 0/7 to 30 6/7 weeks
  3. * Chronologic age \<21 days
  4. * Mother providing breast milk
  1. * Major congenital anomaly
  2. * Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference)
  3. * Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology
  4. * Triplets or higher order multiples
  5. * Plan for redirection of care and/or anticipated death
  6. * Clinically significant renal or hepatic dysfunction
  7. * Inborn error of metabolism
  8. * Fluid restriction \<140 mL/kg/day for 3 or more days
  9. * Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment
  10. * Anticipated transfer \<36 weeks' postmenstrual age
  11. * Parents do not consent to use of pasteurized donor human milk
  12. * Infant in non-parental custody

Contacts and Locations

Principal Investigator

Mandy B Belfort, MD, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Mandy B Belfort, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's 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 Date2020-01-31
Study Completion Date2027-08

Study Record Updates

Study Start Date2020-01-31
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Preterm Birth
  • Breast Milk Expression
  • Nutrition Disorder, Infant
  • Brain Development Abnormality
  • Neurodevelopmental Disorders