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Human Milk Concentrating Device to Optimize Mother's Own Milk
Sponsor: Mother's Milk is Best
Summary
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula. The primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life. Secondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.
Official title: Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk
Key Details
Gender
All
Age Range
32 Weeks - 35 Weeks
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2026-09-01
Completion Date
2028-07-01
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
Human Milk Concentration Device
A sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier.
Standard of Care Fortified Feeding
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
Locations (1)
Yale University
New Haven, Connecticut, United States