Human Milk Concentrating Device to Optimize Mother's Own Milk (NEOMOM)

Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Babies; Preterm Infant Health
• Intervention / Treatment: Device: Human Milk Concentration Device; Other: Standard of Care Fortified Feeding

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Nelson, PhD; Phone Number: 2679818066; Email: enelson@mmib.health

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth Velocity	Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.	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.	14 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Tolerance	Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.	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.	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.	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.	First 28 days of life or until discharge
Length of Stay	Duration of hospitalization in the NICU.	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.	From birth to hospital discharge (up to 10 weeks)

Collaborators and Investigators

• Sponsor: Mother's Milk is Best
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Yale University; Beth Israel Deaconess Medical Center; Weill Medical College of Cornell University
• Investigators: Principal Investigator: Sarah Taylor, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Preterm infants; Human Milk; Human Milk Concentration; NICU Feeding; Neonatal nutrition; Mother's on Milk
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: MMIB-NEOMOM-2000042290; R44HD110306 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 6-12 months following publication and ending 3-5 years after publication.
• IPD Sharing Access Criteria: Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study sponsor to ensure the proposed use is scientifically and ethically appropriate and consistent with participant consent and institutional policies. Data sharing will require execution of a data use agreement and may require Institutional Review Board approval or exemption, as applicable. Data will be shared in a manner that protects participant privacy and confidential information.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No