Human Milk Concentrating Device to Optimize Mother's Own Milk

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.

Conditions

• Preterm Infant Health
• Premature Babies

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Weill Medical College of Cornell University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Mother's Milk is Best

  lead INDUSTRY

Principal Investigators

• Sarah Taylor, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

32 Weeks

Max Age

35 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-03-14

Completion

2028-07-01

FDA Device

Yes

Countries

• United States

Study Locations