Wireless withdrawal detection and monitoring system for neonatal abstinence syndrome.

项目总结 新生儿戒断综合征(NAS)是一种阿片类药物戒断综合征，在出生后不久发展到 宫内暴露的新生儿。NAS的成本很高：患有NAS的新生儿通常在新生儿时期得到护理 重症监护病房(NICU)，那里的日常护理费用很高。近22,000名婴儿出生时都患有NAS 每年花费15亿美元1。此外，用于治疗NAS的药物干预措施可用于 80%接触阿片类药物的婴儿，他们自己都有毒性和药物相互作用的风险2.尽管医疗费用很高， NAS的高度社会影响和治疗风险，评估NAS严重程度的工具可能是主观的 3.迫切需要创新的新方法来诊断NAS和 评估治疗反应的有效性。 灵活、低成本的可穿戴设备(佩戴在皮肤上)，可以报告系统生化和 生物力学方法提供了一种简单而经济的解决方案。在NAS中，交感神经系统的激增 运动会增加心率、皮肤传导性、体温不稳定和震颤。这些都体现在 婴儿出汗增加、癫痫发作、震颤、体温不稳定等--这些事件必须 由护士持续监测和评估。无人监督的、客观的身体检测/量化 患有NAS的新生儿的反应可以推动新的、客观的评分工具的发展，这些工具可以 指导NAS2治疗的开始、强度和持续时间。这样的工具可以显著减少医疗费用 通过减少患者在NICU的时间、减少护士工作量、改善门诊率来降低成本并改善患者预后 监测并协助优化患者的治疗。关键的是，我们认为这样的工具可能 能够客观地捕捉可能未被护士注意到的事件或在婴儿睡觉时(次要事件 震颤、氧合不良、体温波动、脱水)。 这项提议旨在开发、评估和商业化互联的、面向婴儿的可穿戴生物传感器- 能够自动进行数字评分的系统，连续监测生化、心理和 阿片类药物依赖新生儿环境对生物物理参数的影响 NAS。我们的团队和合作伙伴在这项调查开展所需的所有领域都拥有出色的经验 一种商业级可穿戴腕带监测套件，包括：(1)婴儿可穿戴腕带，(2)成像 摄像头(3)充电站，(4)平板APP，(5)为专业医疗保健提供者量身定做的患者门户。 我们的业务部门在NIH资助的可穿戴生物传感、交感神经检测方面拥有丰富的经验 在阿片类药物戒断、儿科、商业发展和知识产权方面的神经系统活动。我们的 学术伙伴在新型生物传感器的开发方面拥有丰富的经验。

PROJECT SUMMARY Neonatal abstinence syndrome (NAS) is an opioid withdrawal syndrome that develops shortly after birth to in utero-exposed neonates. The cost of NAS is high: newborns with NAS are typically receive care in the Neonatal Intensive Care Unit (NICU), where the daily cost of care is high. Nearly 22,000 infants are born with NAS each year at a cost of $1.5 billion 1. Moreover, medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, carry their own risks of toxicity and drug interactions 2. Despite the medical cost, high societal impact of NAS, and the risks of treatment, the tools to assess the severity of NAS can be subjective and suffer from examiner bias 3. There is an urgent need for innovative new methods to diagnose NAS and assess the efficacy of responses to treatment. Flexible, low-cost wearable devices (worn on the skin) that can report measures of systemic biochemical and biomechanical processes offer a simple and economical solution. In NAS, surges of sympathetic nervous system activity produce increased heart rate, skin conductance, unstable temperature, and tremor. These manifest in increased infant sweating, seizures, tremors, unstable body temperature, and more—events that must continually monitored and assessed by nurses. The unsupervised, objective detection/quantification of the bodily response of neonates suffering from NAS could drive the development of new, objective scoring tools that can guide the initiation, intensity, and duration of therapies for NAS2. Such tools could significantly reduce medical costs and improve patient outcomes by reducing patient time in NICU, reducing nurse load, improving outpatient monitoring, and helping to assist in the optimization of patient treatments. Critically, we believe such a tool may be able to objectively capture events that may go unnoticed by nurses or while the infant is sleeping (minor tremors, poor oxygenation, temperature fluctuations, dehydration). This proposal seeks to develop, assess, and commercialize interlinked, infant-targeted wearable biosensor- systems capable of automated digital scoring, continuously monitoring the biochemical, psychological and environmental to biophysical parameters of opioid-dependent neonates while providing suggestive treatment for NAS. Our team and partners have outstanding experience in all areas necessary to this investigation to develop a commercial grade wearable wristband monitoring kit that includes: (1) infant wearable wristband, (2) imaging camera (3) recharging station, (4) tablet app, and (5) patient portal tailored for professional healthcare providers. Our business unit has extensive NIH funded experience in wearable biosensing, in the detection of sympathetic nervous system activity in opioid withdrawal, pediatrics, business development, and intellectual property. Our academic partners have broad experience in novel biosensor development.