Point of Care maternal milk concentration device optimizing neonatal growth with targeted nutrition support: Establishing clinical evidence of benefit as an alternative to milk sourced fortification

Project Summary Human milk is the best feeding option for preterm infants. However, to meet the high nutrient needs of preterm infants in Neonatal Intensive Care Units (NICUs), mother’s own milk (MOM) is often mixed with bovine milk sourced fortifiers to provide adequate nutrients for growth. The Human Milk Concentration (HMC) device is the first of its kind a point of care medical device that uses a gentle osmotic draw to remove water from milk so that preterm infants can receive optimal nutrients as well as bioactives from their own mother’s milk without cow’s milk additives. This is an innovation that embodies the NIH mission of improving healthcare outcomes by providing preterm infants the valuable nutrients only found in mother’s milk, increasing their chance of survival and improved overall health. The HMC device will increase feeding amounts of mother’s own milk fed to preterm infants which impacts immune system, microbiome development and even long-term health by decreasing risk of life-threatening diseases. Given the success of the technology in concentrating mother’s milk and the progress made in the Phase II research, the goal of this proposal is to perform the seminal clinical trial- a 3-site study with specific aims that provide the quantitative evidence required for broad adoption and a paradigm shift in neonatal feeding- the results of which will allow for the commercialization of the device. Mother’s Milk is Best Inc (MMIB)’s Phase IIB objectives are Specific Aim 1) To determine through randomized non-inferiority trial whether preterm infants fed exclusive MOM gently concentrated at point of care will have growth and mineral status similar to infants fed the standard of care which is MOM supplemented with cow’s milk-based products. Specific Aim 2) Assess the cost of feedings and total cost of care using passive concentration of human milk fortifier versus cow’s milk fortifier Specific Aim 3) Determine the best practices for NICU utilization of the human milk concentrating device with parents and NICU staff members involved in human milk concentration during the randomized, controlled trial Once these objectives are met, Mother’s Milk is Best will have the scientific evidence of the HMC benefits by enabling physicians to adopt the technology though a data-based decision, cost and outcomes driven, accelerating the commercialization of this paradigm shift of the standard of care for preterm infant feedings.