Human Milk Concentrating Device to Optimize Mother's Own Milk

Starting soon · Not applicable

Conditions studied: Preterm Infant Health, Premature Babies

In brief

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.

Key facts

Study ID

NCT07576972

Run by

Mother's Milk is Best

People needed

310

Starts

2026-09-01

Expected to finish

2028-07-01

Last updated by the study team

2026-05-08

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth at 32 0/7 to 34 5/7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM
• Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification/supplementation.
• Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.

You may not qualify if…

• Major congenital anomalies
• Contraindication to receiving MOM
• Feeds not started by 2 days post-birth
• Fortification/supplementation not ordered by 5 days post-birth,
• Inadequate MOM for concentration/fortification within 5 days post-birth
• Expected transfer to another hospital
• Expected hospital discharge within 14 days post-birth
• Enrollment in another intervention study with an intervention that could affect infant growth or mineral status
• Infant with contraindications for use of the HMC device

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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