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

项目摘要 母乳为婴儿提供了许多健康益处，包括减少中耳炎、呼吸道疾病和 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婴儿的护理标准。美国儿科学会（AAP）、世界卫生组织 (WHO)和疾病控制和预防中心（CDC）建议在前6个月纯母乳喂养， 理想情况下，直到2岁。母乳本身不足以满足极低出生体重儿（VLBW）的需要， 母亲之间的高度变异性和极低出生体重早产儿和婴儿的更高需求。因此，母乳喂养 早产儿需要营养强化（补充）。标准强化包括添加固定量的 每100毫升人乳中添加的强化剂量为100毫克，是美国最常用的强化方法。固定金额确定 并假设所有人乳含有相同量的蛋白质 和其他大量营养素。母乳中常量营养素组成的这些假设已被证明， 低估了新生儿和婴儿在NICU中接受的蛋白质量，可能导致神经认知功能低下 成果。因此，母乳中常量营养素和微量营养素浓度的快速护理点测试是 这是改善婴儿营养的必要条件，也是有针对性的营养强化的必要条件。 我们提出了一个易于使用的设备，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 母乳中的大量营养素。这些结果将有助于卫生保健提供者根据以下因素确定强化 实际值和减少牛奶样品的常量营养素组成的分析，提供最佳的目标 为最弱势的NICU患者提供营养。此外，快速护理点常量营养素测试将改变 工作流程失败茁壮成长和缓慢增长的婴儿。我们的设备将允许在临床上进行快速准确的诊断 并保证更直接地转诊给儿科专家，如果测试样品的热值， 立即确认热量摄入，以检查发育不全的婴儿。 成功完成拟议的第一阶段计划将提供关键数据，以扩大我们的一个- 这是一项第二阶段计划中的一种技术，将在一项大型临床研究中进行验证。本研究将包括 进一步开发易于使用的母乳护理点测试，并证明我们的测试条作为一种简单的 一种集成到NICU工作流程中的工具，使定制的电子健康记录友好软件能够使我们的试纸 结果进行分析，并促进有针对性的强化和家庭综合治疗。

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.