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

基本信息

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
项目类别：
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

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

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项目摘要

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，可以通过提供NIH的任务来改善医疗保健结果早产婴儿只有在母乳中发现的宝贵营养，从而增加了生存的机会并改善了整体健康状况。这项研究的目的是根据 NICU并证明了降低喂养intlerance和增加生长方面的卓越性能通过两个临床前评估。人牛奶是早产儿的最佳喂养选择。但是，要满足早产儿在新生儿重症监护病房（NICUS）的高营养需求，母亲自己的牛奶通常与牛牛奶采购的堡垒混合在一起，以实现营养水平的目标。这完成任务，牛的牛fortifiers潜力增加了危险的喂养intlerance的风险，负面影响免疫系统，微生物组发展，甚至长期健康增加肺和眼部疾病的风险。这些风险以及婴儿配方的崩溃供应链使迫切需要找到一种替代性更安全，更可用的方法。人类牛奶浓度（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从牛奶中取出一些水，以便早产儿可以从其中获得最佳的营养拥有母亲的牛奶，没有牛奶添加剂，并帮助支持母乳喂养妈妈替代直接移动到公式。工作的成功将进一步带来令人信服的证据该技术支持膜的最终发展阶段的安全性和效率：准备FDA提交，提交和最后的临床测试。母亲的牛奶是Best Inc（MMIB）的 II阶段目标是1）创建针对医疗设备的HMC配方和铸造过程应用2）设计和测试2针对特定用例的产品实施例和3）测试以确定摄食浓度HM对新生儿肠道细胞的影响4）比较喂养浓缩牛奶，不浓缩牛奶和的小鼠的生长指标和肠道健康公式。一旦测试了膜配方，并设置了每个医疗的制造过程设备和HMC要求，MMIB将对设备的安全性和效率充满信心迈向技术在NICU和牛奶库中使用HMC的一步，以帮助早产婴儿蓬勃发展。