Human Milk Concentrating Device to Optimize Mother's Own Milk

NCT07576972 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: MMIB-NEOMOM-2000042290R44HD110306
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human Milk Concentration; NICU Feeding; Neonatal nutrition; Mother's on Milk; Human Milk; Preterm infants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Feeding Tolerance

  Up to 28 days of life or hospital discharge

• Weight Gain Monitoring

  Daily through 28 days of life or discharge

• Feeding Preparation Cost

  Up to 28 days of life or discharge

• Total Feeding Cost

  First 28 days of life or until discharge

• Length of Stay

  From birth to hospital discharge (up to 10 weeks)

Study Arms (2)

HMC-Concentrated MOM

EXPERIMENTAL

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

Standard Fortified Feeding (MOM + Fortifier/Formula)

ACTIVE COMPARATOR

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

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.

HMC-Concentrated MOM

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.

Standard Fortified Feeding (MOM + Fortifier/Formula)

Eligibility Criteria

• Age: 32 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mother's Milk is Best: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Weill Medical College of Cornell University: collaborator
• Yale University: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sarah Taylor, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Nelson, PhD

CONTACT

2679818066; enelson@mmib.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 14, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 6-12 months following publication and ending 3-5 years after publication.
• 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.

Locations

US (1)