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

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.

Description

Eligibility

Age range

0–0 years

Sex

All

Healthy volunteers

No

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.

Location