Point of Care maternal milk concentration device to optimize neonatal growth with targeted nutrition support

Project Summary 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 goal of this research is to tailor the technology to the specific needs of the NICU and prove superior performance in decreasing feeding intolerance and increasing growth through two preclinical evaluations. 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 is often mixed with bovine milk sourced fortifiers to achieve nutrient level goals. This is done despite the bovine sourced fortifiers potential to increase risk of dangerous feeding intolerance, to negatively impact immune system, microbiome development and even long-term health by increasing risk of lung and eye diseases. These risks along with the breakdown of the infant formula supply chain make it an urgent need to find an alternative safer and more available method. The Human Milk Concentration (HMC) device is a safe and simple solution- it uses a passive osmotic process to remove some of the water from milk so that preterm infants can receive optimal nutrients from their own mother’s milk without cow’s milk additives and helps support breast feeding moms providing an alternative to moving straight to formula. The success of the work will further bring convincing evidence of the safety and efficacy of this technology supporting the final development phase of the membrane: preparing for FDA submission, submission and finally clinical testing. Mother’s Milk Is Best Inc (MMIB)’s Phase II objectives are to 1) create an HMC formulation and casting process specific for a medical device application 2) Design and test 2 product embodiments for specific use cases and 3) perform pre-clinical tests to determine the impact of feeding concentrated HM to neonatal gut cell derived enteroids 4) Compare growth metrics and gut health in mice fed concentrated milk, unconcentrated milk and formula. Once the membrane formulation has been tested and fabrication process set per medical device and HMC requirements, MMIB will be confident in the safety and efficacy of the device thus advancing the technology one step toward use of the HMC in the NICU and milk banks to help preterm infants thrive.