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

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是改善健康，降低每年1500万早产或体重严重不足的婴儿的护理成本。这些“早产儿”需要在专门的医院病房（如新生儿重症监护室）接受数周或数月的护理。在美国，一个典型的新生儿重症监护病房的费用约为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的终身并发症的风险很高，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-喂养周期，对新生儿生长和发育的最核心重要因素之一产生重大影响。今天，这个周期是不规则的，断断续续的，几乎80%的时间被打断，这导致住院。如果成功，该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，积累更多的能量，摄入更多的卡路里，使他们的排出速度加快20%。更重要的是，这项技术可以降低与睡眠模式不佳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，临床医生可以使用它来监测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-进食周期的目标。在第一阶段，该团队开发了一种原型传感器，配置用于小婴儿，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，以实现常规可靠使用。对于任何临床医生来说，它应该是简单和非侵入性的，以可靠地定位传感器并在多天内监测任何婴儿。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，以自动工件处理。该团队将开发和测试机器学习例程，这些例程将显示基于脑干的睡眠模式的详细、准确、可靠的瞬时和趋势数据，这些数据目前还无法获得。这些新的进展，建立在新颖的脑干生物测量将开辟广泛采用支持业务的发展和实质性的医学进步。这个奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.