Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07576972

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Preterm Infant Health Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Babies Premature Birth Urogenital Diseases

Age range

32 week–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Growth Velocity

    Time frame: Birth to 28 days of life or hospital discharge, whichever occurs first

    Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.

  2. Serum Phosphate Level

    Time frame: 14 days of life

    Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.

Secondary outcomes

  1. Feeding Tolerance

    Time frame: Up to 28 days of life or hospital discharge

    Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.

  2. Weight Gain Monitoring

    Time frame: Daily through 28 days of life or discharge

    Serial assessment of infant weight to evaluate adequacy of growth during the study period.

  3. Feeding Preparation Cost

    Time frame: Up to 28 days of life or discharge

    Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.

  4. Total Feeding Cost

    Time frame: First 28 days of life or until discharge

    Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.

  5. Length of Stay

    Time frame: From birth to hospital discharge (up to 10 weeks)

    Duration of hospitalization in the NICU.

  6. Total NICU cost of care

    Time frame: From birth to hospital discharge (up to 10 weeks)

    Total hospital costs incurred during NICU stay, including all resources utilized.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Nelson, PhD

CONTACT

[email protected]

2679818066

Sponsors and collaborators

Lead sponsor

Mother's Milk is Best

Industry

Collaborators

  • Beth Israel Deaconess Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Weill Medical College of Cornell University
  • Yale University

Registry information

Official study title

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

Acronym: NEOMOM

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.