Premature Babies, Preterm Infant Health
Conditions
Keywords
Human Milk Concentration, NICU Feeding, Neonatal nutrition, Mother's on Milk, Human Milk, Preterm infants
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.
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
DEVICEHuman 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.
OTHERStandard 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
Mother's Milk is Best
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Beth Israel Deaconess Medical Center
Weill Medical College of Cornell University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 35 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphate Level | 14 days of life | Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy. |
| Growth Velocity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total NICU cost of care | From birth to hospital discharge (up to 10 weeks) | Total hospital costs incurred during NICU stay, including all resources utilized. |
| Feeding Tolerance | 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. |
| Weight Gain Monitoring | Daily through 28 days of life or discharge | Serial assessment of infant weight to evaluate adequacy of growth during the study period. |
| Total Feeding Cost | First 28 days of life or until discharge | Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time. |
| Feeding Preparation Cost | Up to 28 days of life or discharge | Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy. |
| Length of Stay | From birth to hospital discharge (up to 10 weeks) | Duration of hospitalization in the NICU. |
Countries
United States
Contacts
CONTACTElizabeth Nelson, PhD
PRINCIPAL_INVESTIGATORSarah Taylor, MD
Yale University
Outcome results
None listed