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Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
Sponsor: Brigham and Women's Hospital
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.
Key Details
Gender
All
Age Range
1 Day - 21 Days
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2020-01-31
Completion Date
2027-08-31
Last Updated
2025-06-17
Healthy Volunteers
No
Conditions
Interventions
Individually targeted fortification
Abbott liquid protein and/or medium chain triglyceride are added routinely to ensure that the "base" milk has protein 1 g/dL and calories 67/dL.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States