Development of a point of care test-strip kit to quantify breastmilk nutrient profile

项目总结 母乳对婴儿的健康有许多好处，包括减少中耳炎、呼吸系统疾病和 胃肠道感染、哮喘、婴儿猝死综合症，以及肥胖和糖尿病的可能性降低。 这是NICU婴儿护理的标准。美国儿科学会(AAP)，世界卫生组织 (世卫组织)和疾病控制和预防中心(CDC)建议在前6个月和 理想的情况是直到2岁。单靠母乳不足以满足极低出生体重(VLBW)婴儿的需求，因为 母亲的变异性高，早产儿和婴儿对极低出生体重的需求更高。因此，母乳喂养到 早产儿需要补充营养。标准防御工事包括添加固定数量的 每100毫升母乳中含有大量的强化剂，是美国使用最多的强化方法。确定定额 由母乳强化剂制造商提出，并假设所有母乳含有相同数量的蛋白质 和其他常量营养素。这些关于母乳中大量营养素组成的假设已被证明 低估了NICU中新生儿和婴儿的蛋白质摄入量，可能导致神经认知能力低下 结果。因此，对母乳中的常量营养素和微量营养素浓度进行快速护理测试的方法是 这是改善婴儿营养的当务之急，也是定向强化的关键。 我们提供了一个简单易用的设备，其中包括一个测试条，与我们的智能手机应用程序相结合，以快速量化 母乳中的常量营养素。这些结果将帮助医疗保健提供者根据以下情况确定防御工事 牛奶样品的常量营养素组成的实际值和减少猜想，提供最佳的靶向 为最脆弱的NICU患者提供营养。此外，快速的医疗点常量营养素测试将改变 婴儿发育不良和发育迟缓的工作流程。我们的设备将允许在临床上进行快速准确的诊断 并保证更多的立即转诊给儿科专家，例如，如果测试了样本的卡路里价值，那么可能会有 立即确认卡路里摄入量，以纠正发育不健全的婴儿。 成功完成拟议的第一阶段计划将为我们的One-of-a-a-a扩展开发提供关键数据 Kind技术在第二阶段计划中，将适合在大型临床研究中进行验证。这项研究将包括 进一步开发易于使用的母乳护理点测试，并演示使用我们的测试试纸作为一种简单的 集成到NICU工作流程中的工具，支持定制的电子健康记录友好软件，以支持我们的测试试纸 对结果进行分析，以利于有针对性的防御和家庭综合治疗。

PROJECT SUMMARY Breast milk provides numerous health benefits for infants including reduced illnesses such as otitis media, respiratory and gastrointestinal infections, asthma, sudden infant death syndrome, and a reduction in the likelihood of obesity and diabetes. It is the standard of care for NICU infants. The American Academy of Pediatrics (AAP), World Health Organization (WHO), and Center for Disease Control and Prevention (CDC) recommend exclusive breastfeeding the first 6 months and ideally until age 2. Breastmilk alone is not adequate to meet the needs of very low birth weight (VLBW) infants due to the high variability amongst mothers and higher needs of VLBW preterm neonates and infants. Therefore, human milk fed to preterm infants requires fortification (supplementation) with nutrients. Standard fortification involves adding a fixed amount of fortifier per 100ml of human milk and is the most utilized fortification method in the US. The fixed amount is determined by the manufacturer of the human milk fortifier and assumes that all human milk contains the same amount of protein and other macronutrients. These assumptions of the macronutrient composition of human milk have been shown to underestimate the amount of protein a neonate and infant in the NICU is receiving and can lead to poor neurocognitive outcomes. Therefore, a rapid point of care test for macronutrient and micronutrient concentrations in breast milk is imperative for improving infant nutrition and essential for targeted fortification. We present an easy-to-use device that includes a test strip coupled with our smartphone application to rapidly quantify macronutrients in human milk. These results will help a health care provider determine the fortification based on actual values and decrease conjectures for macronutrient composition of a milk sample, providing optimal targeted nutrition for the most vulnerable NICU patients. Further, the rapid point of care macronutrients test will change the workflow for failure to thrive and slow growth infants. Our device will allow for rapid and accurate diagnosis in the clinic and warrant more immediate referral to pediatric specialists e.g., if the caloric value of a sample is tested then there may be immediate confirmation of caloric intake for the work-up of failure to thrive infants. Successful completion of the proposed Phase I program will provide critical data to expand development of our one-of-a- kind technology in a Phase II program that will be geared towards validation in a large clinical study. This study will include further development of easy-to-use point of care tests in human milk and demonstrate the use of our test strip as an easy tool to integrate into NICU workflow enabling a custom electronic health record-friendly software to allow for our test strip results to be analyzed and facilitate targeted fortification and family integrated therapy.