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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Preterm Birth
Intervention / Treatment

-

Contacts and Locations

Boston

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

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

  • * Inpatient in Brigham and Women's Hospital NICU
  • * Gestational age 24 0/7 to 30 6/7 weeks
  • * Chronologic age \<21 days
  • * Mother providing breast milk
  • * Major congenital anomaly
  • * Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference)
  • * Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology
  • * Triplets or higher order multiples
  • * Plan for redirection of care and/or anticipated death
  • * Clinically significant renal or hepatic dysfunction
  • * Inborn error of metabolism
  • * Fluid restriction \<140 mL/kg/day for 3 or more days
  • * Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment
  • * Anticipated transfer \<36 weeks' postmenstrual age
  • * Parents do not consent to use of pasteurized donor human milk
  • * Infant in non-parental custody

Ages Eligible for Study

1 Day to 21 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

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

Study Record Dates

2026-12-31