SBIR Phase I: Development and Testing of a Mini Wearable Device that Doctors Can use to Know if it is too Soon or Not to Send A premature Baby Home

SBIR 第一阶段：开发和测试迷你可穿戴设备，医生可以用它来判断是否太早送早产儿回家

• 批准号: 1648567
• 负责人: Mike Baltay
• 金额: $ 22.5万
• 依托单位: BrainStem Biometrics
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-15 至 2018-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1648567&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Testing; Mini

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project would be to make it safer to send premature babies home after their stay in the NICU. They will be more likely to grow and thrive while they regain valuable bonding time with their parents. The risk of having to readmit babies would go down. Complications and maybe even SIDS could be reduced, because we would have a better way to measure and understand the development of these babies after they leave the hospital but continue to mature for the first year. Our physicians are excellent, but their decisions can only be as reliable as the information they are provided. Many cases doctors are forced to make difficult decisions between keeping a baby longer at greater cost and further separation or sending the baby home to begin a new life, but at the risk that the baby's central nervous system may not be quite up to the job of keeping the basic heart, lung and temperature at the right levels. This project will give physicians better more accurate information to reduce the guesswork and keep the babies safe.The proposed project will result in a miniature throw away sensor strip that nurses stick on the outer eyelid of a premature baby. The technology, called OMT allows us to read the innermost control signals of the deepest and most important part of the brain called the brainstem. Neuroscientists now know that one of the most important jobs that the brainstem does is to help control the most basic primitive life functions such as changing the rate of breathing, body temperature, blood pressure and heart rate. Develop a thin film sensor and instrument that is capable of successfully recording brainstem biosignals in premature babies, both technically and physiologically, and; demonstrate that it is possible to distinguish between pre-terms with and without discharge problems The project plan is to complete the design and assembly of the instrument and to sample the data from a late pre-term infant to determine basic viability of signal and satisfactory detection. Following that the team will produce a small lot of sensors and several test units to measure 9-18 young patients in three cohorts. This basic validation of the instrument and clinical value is the key next step to successful commercialization of the product.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力将使早产儿在NICU停留后更安全地送回家。他们将更有可能成长和茁壮成长，而他们重新获得宝贵的时间与他们的父母。不得不重新接纳婴儿的风险会降低。并发症甚至是SIDS都可以减少，因为我们有更好的方法来测量和了解这些婴儿在离开医院后的发育情况，但在第一年继续成熟。我们的医生是优秀的，但他们的决定只能像他们提供的信息一样可靠。在许多情况下，医生被迫做出艰难的决定，是以更高的成本延长婴儿的寿命，还是进一步分离婴儿，还是将婴儿送回家开始新的生活，但这可能会使婴儿的中枢神经系统无法完全胜任将基本的心脏，肺和体温保持在正确水平的工作。该项目将为医生提供更好更准确的信息，以减少猜测，并保持婴儿的安全。拟议的项目将导致一个微型的一次性传感器带，护士贴在早产儿的外眼睑。这项名为OMT的技术允许我们读取大脑最深处和最重要部分脑干的最深处控制信号。神经科学家现在知道，脑干所做的最重要的工作之一是帮助控制最基本的原始生命功能，如改变呼吸频率，体温，血压和心率。 开发一种薄膜传感器和仪器，能够在技术和生理上成功记录早产儿的脑干生物信号;项目计划是完成仪器的设计和组装，并从一个较晚的预测试中抽取数据，足月儿确定信号基本活力和满意检测。接下来，该团队将生产一小批传感器和几个测试单元，以测量三个队列中的9-18名年轻患者。仪器和临床价值的基本验证是产品成功商业化的关键下一步。