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

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.

项目概要这是一项创新，体现了 NIH 的使命：通过提供早产儿仅在母乳中发现的宝贵营养可增加他们的生存机会并改善整体健康状况。这项研究的目标是根据特定需求定制技术。 NICU 并证明在减少喂养不耐受和促进生长方面具有卓越的性能通过两项临床前评估，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，母乳通常与牛乳强化剂混合以达到营养水平目标。尽管牛源强化剂可能会增加危险的喂养不耐受的风险，对免疫系统、微生物组发育甚至长期健康产生负面影响这些风险随着婴儿配方奶粉的分解而增加。供应链使得人类迫切需要找到一种更安全、更可用的替代方法。牛奶浓缩 (HMC) 装置是一种安全且简单的解决方案 - 它使用被动渗透过程来从母乳中去除部分水分，以便早产儿能够从母乳中获得最佳营养自己的母乳不含牛奶添加剂，有助于支持母乳喂养妈妈提供这项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开发阶段的安全性和有效性：准备 FDA 提交、提交以及最后的 Mother’s Milk Is Best Inc (MMIB) 的临床测试。第二阶段的目标是 1) 创建特定于医疗器械的 HMC 配方和铸造工艺应用 2) 设计和测试特定用例的 2 个产品实施例，以及 3) 执行临床前确定喂养浓缩 HM 对新生儿肠道细胞衍生肠类的影响的测试 4) 比较喂食浓缩牛奶、非浓缩牛奶和牛奶的小鼠的生长指标和肠道健康状况一旦膜配方经过测试并根据医学设定制造工艺。设备和 HMC 要求，MMIB 对设备的安全性和有效性充满信心，从而推动技术向前迈出一步，在新生儿重症监护病房 (NICU) 和母乳库中使用 HMC 来帮助早产婴儿茁壮成长。