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

母乳是早产儿的最佳喂养选择。然而，由于美国新生儿重症监护室（NICU）中早产儿的高营养需求，母亲的母乳最常与牛乳来源的强化剂混合，以达到目标营养水平。母乳浓缩（HMC）设备通过去除水分来浓缩母乳，使得早产儿可以从自己的母乳中获得足够的营养，而不依赖于可能导致喂养不耐受的当前强化剂。这是一项创新，体现了NIH的使命，即通过为早产儿提供仅在母乳中发现的有价值的营养物质来提高他们的生存机会，从而改善医疗保健结果。本研究的目的是了解该设备的技术能力以及采用所需的临床要求，以便该设备可以作为第一种强化牛奶的产品进行商业化，而不会损失强化剂中未发现的关键生物活性物质和营养素。在具体目标1中，我们通过量化HMC设备用于浓缩生母乳时的浓度水平来研究这些关键营养素。还将确认在该过程中没有营养物质被破坏或变性。在具体目标2中，将进行研究，为NICU实际采用HMC器械创建证据基础。根据全面的客户研究计划，将创建器械的临床工作流程和要求。将优化用户协议，以使浓缩母乳的营养密度保持一致，降低污染风险，并防止无意中误用。这些研究将为在NICU中使用HMC帮助早产儿茁壮成长奠定坚实的基础。

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.