An interventional study of Human Milk Concentration Device and Standard of Care Fortified Feeding in Preterm Infant Health and Premature Babies, sponsored by Mother's Milk is Best. Not yet recruiting at 1 site in United States. Open to participants aged 32 Weeks to 35 Weeks. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Mother's Milk is Best · Not applicable, Interventional, and Supportive care
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.
Preterm infants often require nutritional supplementation to support adequate growth and bone mineralization during hospitalization. Current standard of care commonly involves the addition of cow's milk-based fortifiers or formula to mother's own milk (MOM), which may introduce variability in feeding practices, added cost, and exposure to non-human milk components.
This study evaluates a human milk concentration (HMC) device designed to increase the nutrient density of MOM through passive water removal using forward osmosis. The device enables concentration of MOM without the addition of bovine-derived products and is intended to integrate into existing neonatal intensive care unit (NICU) feeding workflows.
The study is a randomized, controlled, non-inferiority trial conducted in preterm infants receiving enteral nutrition in the NICU. Participants are assigned to receive either MOM concentrated using the HMC device or standard of care feeding consisting of MOM with supplementation per institutional practice. Feeding preparation and administration are performed according to site-specific protocols.
Clinical assessments are conducted throughout the study period to evaluate infant growth, nutritional status, and overall clinical stability. Safety monitoring includes routine clinical evaluations and laboratory assessments consistent with standard NICU care. In addition, data are collected to assess resource utilization and costs associated with feeding preparation and overall care during hospitalization.
The goal of this study is to generate evidence on whether concentrating MOM using the HMC device can provide a clinically comparable alternative to standard supplementation practices while potentially reducing reliance on bovine-derived products and impacting healthcare resource utilization.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 310 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers.
Device: Human Milk Concentration Device
Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care.
Other: Standard of Care Fortified Feeding
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.
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
Growth Velocity
Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
Time frame: Birth to 28 days of life or hospital discharge, whichever occurs first
Serum Phosphate Level
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
Time frame: 14 days of life
Feeding Tolerance
Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.
Time frame: Up to 28 days of life or hospital discharge
Weight Gain Monitoring
Serial assessment of infant weight to evaluate adequacy of growth during the study period.
Time frame: Daily through 28 days of life or discharge
Feeding Preparation Cost
Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
Time frame: Up to 28 days of life or discharge
Total Feeding Cost
Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
Time frame: First 28 days of life or until discharge
Length of Stay
Duration of hospitalization in the NICU.
Time frame: From birth to hospital discharge (up to 10 weeks)
Total NICU cost of care
Total hospital costs incurred during NICU stay, including all resources utilized.
Time frame: From birth to hospital discharge (up to 10 weeks)
Plan to share: Yes — IPD Description: De-identified individual participant data underlying the results reported in this study, including baseline characteristics and outcome measures, may be shared. Access Criteria: Data will be made available to qualified researchers upon reasonable request, subject to review and approval by the study sponsor. Access will require a data use agreement and must comply with applicable privacy and regulatory requirements.
Supporting information: Csr
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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