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NCT03977259
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
Conditions: Preterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development Abnormality, Neurodevelopmental Disorders
Sex: All
Ages: 1 Day – 21 Days
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Inpatient in Brigham and Women's Hospital NICU
* Gestational age 24 0/7 to 30 6/7 weeks
* Chronologic age \
Source: ClinicalTrials.gov (NCT03977259). StuddyBuddy aggregates publicly available trial information.
