Human Milk Concentrating Device to Optimize Mother's Own Milk

Official title

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

Overview

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.

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.

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.

Primary outcome measures

• Growth Velocity [Time frame: Birth to 28 days of life or hospital discharge, whichever occurs first]
• Serum Phosphate Level [Time frame: 14 days of life]

Secondary outcome measures (6)

• Feeding Tolerance [Time frame: Up to 28 days of life or hospital discharge]
• Weight Gain Monitoring [Time frame: Daily through 28 days of life or discharge]
• Feeding Preparation Cost [Time frame: Up to 28 days of life or discharge]
• Total Feeding Cost [Time frame: First 28 days of life or until discharge]
• Length of Stay [Time frame: From birth to hospital discharge (up to 10 weeks)]
• Total NICU cost of care [Time frame: From birth to hospital discharge (up to 10 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Yale University — New Haven

Identifiers

NCT: NCT07576972 · MMIB-NEOMOM-2000042290 · R44HD110306

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗