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

护理点母乳浓缩装置通过有针对性的营养支持优化新生儿生长

• 批准号: 10697455
• 负责人: Elizabeth Randall Nelson
• 金额: $ 103.2万
• 依托单位: MOTHER'S MILK IS BEST, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697455
• 关键词: Breast Feeding; Cattle; Cells; Child; Clinical Trials; Dangerousness; Development; Devices; Duodenum; Experimental Models; Eye diseases; Filler; Formulation; Funding; Goals; Growth; Health; Health Benefit; Human Milk; Immune system; Infant formula; Intake; Intestines; Lung diseases; Medical; Medical Device; Membrane; Methods; Milk; Milk Banks; Mission; Modeling; Mothers; Mus; Neonatal; Neonatal Intensive Care Units; Nutrient; Osmosis; Output; Performance; Phase; Polymers; Preclinical Testing; Premature Infant; Process; Regulation; Reporting; Research; Risk; Safety; Source; System; Techniques; Technology; Temperature; Testing; Time; United States National Institutes of Health; Water; Work; care outcomes; commercialization; design; efficacy validation; experimental study; fabrication; feeding; fortification; gut health; improved; innovation; manufacture; mechanical properties; microbiome; mouse model; neonatal human; neonatal mice; nutrition; point of care; preclinical evaluation; pregnant; prototype; research clinical testing; success; supply chain

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.

项目摘要 这是一项创新，体现了NIH通过提供 早产儿只有在母乳中才能找到的有价值的营养物质增加了他们存活的机会 并改善整体健康状况。这项研究的目标是根据特定的需求调整技术 NICU和Proven在减少喂养不耐受和促进生长方面表现优异 通过两次临床前评估。母乳是早产儿的最佳喂养选择。 然而，为了满足新生儿重症监护病房(NICU)早产儿的高营养需求， 为了达到营养水平的目标，母亲自己的牛奶经常与牛乳来源的强化剂混合在一起。这 尽管牛来源的强化剂可能会增加危险的喂养不耐受的风险， 通过以下方式对免疫系统、微生物群发育甚至长期健康产生负面影响 增加肺部和眼部疾病的风险。这些风险以及婴儿配方奶粉的崩溃 供应链迫切需要寻找一种替代的、更安全、更可行的方法。《人类》 牛奶浓缩(HMC)设备是一种安全而简单的解决方案-它使用被动渗透过程来 去除牛奶中的一些水分，这样早产儿就可以从他们的乳汁中获得最佳的营养 自己的母乳不含牛奶添加剂，并帮助支持母乳喂养的母亲提供 而不是直接转向配方奶粉。这项工作的成功将进一步带来令人信服的证据 支持膜的最终开发阶段的这项技术的安全性和有效性： 准备FDA提交，提交，最后进行临床测试。母乳是最好的公司(MMIB)S 第二阶段的目标是1)创建一种针对医疗器械的HMC配方和铸造工艺 应用2)针对特定用例设计和测试2个产品实施例，以及3)执行临床前 确定饲喂浓缩型HM对新生儿肠道细胞来源肠样细胞的影响的试验4) 比较饲喂浓缩奶、非浓缩奶和非浓缩奶小鼠的生长指标和肠道健康 配方。一旦薄膜配方经过测试并按照医疗标准设定了制造工艺 设备和HMC要求，MMIB将对设备的安全性和有效性充满信心，从而 推动技术进步朝着在NICU和母乳银行使用HMC帮助早产迈出了一步 婴儿茁壮成长。