Human Milk Concentration Device; Point of Care Technology for Feeding Preterm Infants in Intensive Care

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Human milk is the best feeding option for preterm infants. However, due to the high nutrient needs of preterm infants in US Neonatal Intensive Care Units (NICUs), the mother’s own milk is most often mixed with bovine milk sourced fortifiers to achieve goal nutrient levels. The Human Milk Concentration (HMC) device concentrates a mother’s milk by removing water so that preterm infants can receive adequate nutrients from their own mother’s milk and not rely on the current fortifiers which can cause feeding intolerance. This is an innovation that embodies the NIH mission of improving health care outcomes by providing preterm infants the valuable nutrients only found in mother’s milk increasing their chance of survival. The goal of this research is to understand the technical capabilities of this device in parallel with the clinical requirements required for adoption so that this device can be commercialized as the first product to fortify milk without the loss of key bioactives and nutrients not found in fortifiers. In specific aim 1, we study these key nutrients by quantifying the levels of concentration when the HMC device is used to concentrate raw mother’s milk. It will also be confirmed that no nutrient was destroyed or denatured during the process. In specific aim 2, research will be conducted to create an evidence base for practical adoption of HMC device use in NICUs. Based on a comprehensive voice of customer research plan, the clinical workflow and requirements for the device will be created. The user protocol will be optimized to create consistency in the nutrient density of concentrated mother’s own milk, reduce risk of contamination, and prevent inadvertent misuse. Together these studies will create a powerful base for the use of the HMC in the NICU to help preterm infants thrive.