Human Milk Concentrating Device to Optimize Mother's Own Milk

Conditions

• Premature Babies
• Preterm Infant Health

Eligibility Criteria

Sex

ALL

Age

32 Weeks - 35 Weeks

Healthy Volunteers

Not accepted

Interventions

• Human Milk Concentration Device — 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 — OTHER
  Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.

Study Details

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 Dates

Start date

Sep 1, 2026

Status verified

May 2026

Primary completion

Mar 14, 2027

Completion

Jul 1, 2028

Study Design

Enrollment

310 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: HMC-Concentrated MOM
  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.
• Active Comparator: Standard Fortified Feeding (MOM + Fortifier/Formula)
  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.

Primary Outcome Measure

Growth Velocity [ Time Frame: Birth to 28 days of life or hospital discharge, whichever occurs first ]

Central Contacts

• Elizabeth Nelson, PhD
  2679818066
  [email protected]

Locations (1)

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