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

这项小企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是改善每年1500万早产儿或严重体重不足婴儿的健康状况并降低护理成本。这些“早产儿”需要在专科医院（如新生儿重症监护室）接受数周或数月的护理。在美国，典型的新生儿重症监护室住院费用约为8万美元，而生命第一年的医疗保健总费用约为每年160亿美元。这些婴儿患一系列严重终身并发症的风险很高，给社会造成了超过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-喂养周期，对新生儿生长发育最核心的重要因素之一产生重大影响。如今，这个周期几乎80%的时间都是不规则的、断断续续的和中断的，这延长了住院时间。如果成功，这个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，积累更多的能量，摄入更多的卡路里，这样他们就可以把排出的速度提高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。这个小型企业创新研究（SBIR）二期项目将研发一种简单的微型可穿戴贴片和显示系统，临床医生可以用它来监测新生儿的睡眠和发育模式。这个新工具将帮助临床医生实现改善睡眠-觉醒-进食周期的目标。在第一阶段，该团队开发了一个用于小婴儿的传感器原型，并证明了它可以用来精确测量睡眠周期。在第二阶段，主要目标是提高该仪器的设计和性能，使其能够日常可靠地使用。它应该是简单和非侵入性的任何临床医生可靠地定位传感器和监测任何婴儿多日期间。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，以改善附件，放大器电路建模，以扩大动态范围和信号处理，以自动化工件处理。该团队将开发和测试机器学习程序，这些程序将显示详细、准确、可靠的基于脑干的睡眠模式的即时和趋势数据，这是目前无法获得的。这些新的进展，建立在新颖的脑干生物测量上，将开辟广泛的应用，支持商业发展和实质性的医学进步。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值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.