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

这个小企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力将是使早产儿在NICU住院后送回家更安全。当他们重新获得与父母相处的宝贵时间时，他们将更有可能成长和茁壮成长。不得不重新接纳婴儿的风险将会下降。并发症甚至SID可能会减少，因为我们将有更好的方法来衡量和了解这些婴儿出院后的发育情况，但在第一年继续发育。我们的医生是优秀的，但他们的决定只能与他们所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，是以更高的成本让婴儿存活更长时间，还是让婴儿进一步分离，还是把婴儿送回家开始新的生活，但风险是，婴儿的中枢神经系统可能无法完全胜任将基本心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，保障婴儿的安全。拟议中的项目将产生一种微型丢弃传感器条，护士可以将其粘贴在早产儿的外眼皮上。这项名为OMT的技术允许我们读取大脑最深、最重要的脑干部分的最内部控制信号。神经学家现在知道，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，并证明可以区分有和没有排出问题的早产儿。项目计划是完成仪器的设计和组装，并从早产儿晚期采集数据，以确定信号的基本可行性和令人满意的检测。随后，该团队将生产少量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。这种对该仪器和临床价值的基本验证是该产品成功商业化的关键下一步。

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.