Human Milk Concentrating Device to Optimize Mother's Own Milk

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• Serum Phosphate Level — 14 days of life
  Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.

Trial sites (1)