SBIR Phase II: Non-invasive Neonatal Brainstem Monitoring to Improve Sleep, Minimize Disruptions and Enhance Feeding Stamina Leading to Earlier Discharge and Healthier Development

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是改善健康并降低每年1500万早产或严重体重不足婴儿的护理成本。这些“前科”需要在专门的医院单元(如NICU)中进行数周或数月的护理。在美国，一次典型的NICU住院费用约为8万美元，而生命第一年的医疗保健总成本约为每年160亿美元。这些婴儿患上一系列严重的终生并发症的风险很高，这些并发症给社会带来了超过300亿美元的经济负担。该项目有可能通过改善婴儿的睡眠-觉醒-喂养循环，对新生儿生长和发育最核心的关键因素之一产生实质性影响。今天，这一周期是不规则的、间歇性的，几乎80%的时间被打乱，从而延长了住院时间。如果成功，这一项目和技术将为临床医生提供一种新的工具和方法，帮助婴儿建立规律性，积累更多能量，吸收更多卡路里，从而使他们的排泄速度加快20%。更重要的是，这项技术可以降低与不良睡眠模式直接相关的下游神经发育并发症的发生率。这项小型企业创新研究(SBIR)第二阶段项目将产生一种简单的微型可穿戴贴片和显示系统，临床医生可以使用该系统来监控新生儿的睡眠和发育模式。这一新工具将帮助临床医生实现改善睡眠-觉醒-喂养周期的目标。在第一阶段，该团队开发了一个原型传感器，可以在婴儿身上工作，并证明它可以用来准确测量睡眠周期。在第二阶段，主要目标是改进该仪器的设计和性能，使其能够正常可靠地使用。对于任何临床医生来说，它应该是简单且非侵入性的，以便可靠地定位传感器并对任何婴儿进行多天的监测。分析数据应以易于解释和可操作的格式实时呈现。这项工作包括进一步的生物医学工程以改善附着，建立放大器电路模型以扩大动态范围，以及信号处理以实现人工制品处理的自动化。该团队将开发和测试机器学习例程，以显示基于脑干的睡眠模式的详细、准确和可靠的瞬时和趋势数据，这些数据目前尚不存在。这些建立在新的脑干生物测量基础上的新进展将开启广泛的采用，支持业务的发展和实质性的医学进步。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is improved health and lowered cost of care for 15 million babies who are born prematurely or severely underweight each year. These 'premies' require weeks or months of care in specialized hospital units (e.g. NICU). In the United States, a typical NICU stay costs about $80K, and the total cost of healthcare during the first year of life is about $16B annually. These babies are at elevated risk for a range of serious lifelong complications that economically burden society by over $30B. This project has the potential to make a substantial impact to one of the most core vital elements of neonatal growth and development by improving the baby's sleep-wake-feed cycle. Today that cycle is irregular, episodic and disrupted almost 80% of the time which prolongs hospitalization. If successful, this project and technology would provide clinicians with a new tool and approach to help babies establish regularity, build up more energy and take on more calories so they can be discharged 20% faster. More importantly, this technology could lower the rate of downstream neuro developmental complications which are linked directly to poor sleep patterns.This Small Business Innovation Research (SBIR) Phase II project will result in a simple miniature wearable patch and display system that clinicians can use to monitor neonatal sleep and development patterns. This new tool will help clinicians achieve their goals of improving sleep-wake-feed cycles. In Phase I the team developed a prototype sensor configured to work on tiny babies and demonstrated that it could be used to accurately measure sleep cycles. In Phase II, the main objective is to advance the design and performance of this instrument to enable routine reliable use. It should be simple and non-intrusive for any clinician to reliably position the sensor and monitor any baby for multi-day periods. Analysis data should be presented real-time in an easy-to-interpret and actionable format. The work includes further biomedical engineering to improve attachment, amplifier circuit modelling to widen dynamic range and signal processing to automate artifact handling. The team will develop and test machine learning routines that will display detailed accurate and reliable instantaneous and trend data of brainstem-based sleep patterns that are not available today. These new advances, built on novel brainstem biomeasures will open up broad adoption supporting the development of a business and substantial medical advances.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.