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病房(NICU)对早产儿的营养需求很高，母亲通常会将自己的牛奶与牛奶来源的强化剂混合，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，以便早产儿能够从自己的母乳中获得足够的营养，而不会依赖目前可能导致喂养不耐受的强化剂。这是一项创新，体现了美国国立卫生研究院的使命，即通过为早产儿提供仅存在于母乳中的宝贵营养物质来改善卫生保健结果，增加他们的存活机会。这项研究的目标是了解该设备的技术能力，同时了解采用该设备所需的临床要求，以便该设备可以作为第一种强化牛奶的产品商业化，而不会损失强化剂中没有的关键生物活性和营养物质。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物质。还将确认在此过程中没有任何营养物质被破坏或变性。在具体目标2中，将进行研究，为在NICU中实际采用HMC设备创建证据基础。根据全面的客户语音研究计划，将创建该设备的临床工作流程和要求。用户协议将得到优化，以使浓缩母乳的营养密度保持一致，降低污染风险，并防止无意中的误用。总而言之，这些研究将为在NICU使用HMC帮助早产儿茁壮成长奠定强大的基础。

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.