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

母乳浓缩装置；

• 批准号: 9754485
• 负责人: Elizabeth Randall Nelson
• 金额: $ 22.36万
• 依托单位: MOTHER'S MILK IS BEST, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-05 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9754485
• 关键词: Address; Adoption; Care Technology Points; Cattle; Child; Clinical; Devices; Dietitian; Energy Intake; Engineering; Ensure; Environment; Enzymes; Ethnography; Filtration; Goals; Health Benefit; Human Milk; Instruction; Intensive Care; Measures; Mechanics; Methods; Milk; Mission; Modification; Mothers; Neonatal; Neonatal Intensive Care Units; Neonatal Nursing; Nutrient; Oligosaccharides; Outcome; Phase; Population; Premature Infant; Process; Protocols documentation; Publications; Research; Risk; Safety; Site Visit; Source; Stem cells; Technology; Testing; United States National Institutes of Health; Voice; Water; Work; base; care outcomes; clinical practice; commercialization; density; design; evidence base; feeding; fortification; improved; innovation; knowledge base; novel; nutrition; prevent

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.

母乳是早产儿的最佳喂养选择，但是，由于美国新生儿重症监护病房 (NICU) 中的早产儿对营养的需求很高，因此母亲的母乳通常与牛乳强化剂混合以达到目标营养水平。母乳浓缩（HMC）装置通过去除水分来浓缩母乳，使早产儿能够从自己的母乳中获得足够的营养，而不是依赖于当前的母乳。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宝贵营养物质来提高其生存机会，从而改善医疗保健结果。这项研究的目标是了解技术能力。该设备的设计与采用所需的临床要求并行，以便该设备可以作为第一个强化牛奶的产品商业化，而不会损失强化剂中未发现的关键生物活性物质和营养物质。在具体目标 1 中，我们研究了这些。通过量化 HMC 设备浓缩母乳时的浓度水平，确定关键营养成分。在具体目标 2 中，将进行研究以创建证据基础。为了在 NICU 中实际采用 HMC 设备，将根据客户研究计划的综合意见，创建该设备的临床工作流程和要求，以实现浓缩母乳营养密度的一致性。 , 降低风险这些研究将为在 NICU 中使用 HMC 来帮助早产儿茁壮成长奠定坚实的基础。