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

项目摘要 这一创新体现了NIH的使命，即通过提供 早产儿只有在母乳中才能找到的有价值的营养素增加了他们的生存机会 并改善整体健康状况。这项研究的目标是使这项技术适应以下方面的具体需求： 在减少喂养不耐受和促进生长方面证明了其上级性能 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室（NICU）中早产儿的高营养需求， 母亲自己的乳汁通常与牛乳来源的强化剂混合以达到营养水平目标。这 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， 增加肺部和眼部疾病的风险。这些风险沿着婴儿配方奶粉的崩溃 供应链使得迫切需要找到一种替代更安全和更可用方法。人类 牛奶浓缩（HMC）设备是一种安全简单的解决方案-它使用被动渗透过程， 从牛奶中去除一些水分，以便早产儿可以从他们的婴儿中获得最佳的营养。 没有牛奶添加剂的母乳，并帮助支持母乳喂养的妈妈提供一个 而不是直接吃配方奶这项工作的成功将进一步带来令人信服的证据 该技术支持膜最终开发阶段的安全性和有效性： 准备FDA提交，提交和最终临床测试。Mother's Milk Is Best Inc（MMIB） 阶段II的目标是1）创建医疗器械专用的HMC配方和铸造工艺 2）针对特定用例设计和测试2个产品实施例，以及3）进行临床前 测定饲喂浓缩HM对新生儿肠细胞衍生的类肠体的影响的试验4） 比较喂食浓缩奶、非浓缩奶和浓缩奶的小鼠的生长指标和肠道健康状况。 公式一旦膜配方已经过测试，并且制造工艺按照医疗要求设定， 器械和HMC要求，MMIB将对器械的安全性和有效性充满信心，因此 将HMC在NICU和母乳银行中的使用技术向前推进了一步，以帮助早产儿 婴儿茁壮成长。

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.