Wireless withdrawal detection and monitoring system for neonatal abstinence syndrome.

新生儿戒断综合征无线戒断检测和监测系统。

• 批准号: 10013069
• 负责人: Shiva Sharareh
• 金额: $ 22.5万
• 依托单位: REKOVAR INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10013069
• 关键词: Accelerometer; Acoustics; Adult; Algorithms; Ambulatory Monitoring; Area; Biochemical; Biomechanics; Biometry; Biosensing Techniques; Biosensor; Birth; Blood; Body Temperature; Breathing; Businesses; Caregivers; Caring; Chest; Computers; Custom; Data; Data Analyses; Data Engineering; Dehydration; Detection; Development; Devices; Diagnosis; Drug Interactions; Eating; Electroencephalography; Event; Family; Funding; Galvanic Skin Response; Guidelines; Heart Rate; Hospital Costs; Hospitals; Hydration status; Infant; Intellectual Property; Intervention; Investigation; Length of Stay; Machine Learning; Measures; Mechanics; Medical Care Costs; Methodology; Methods; Minor; Monitor; Motion; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Newborn Infant; Nurses; Opiate Addiction; Patient-Focused Outcomes; Patients; Pattern; Pediatrics; Pharmaceutical Preparations; Pharmacological Treatment; Physiological; Play; Procedures; Process; Pulse Oximetry; Reporting; Research; Risk; Seizures; Severities; Skin; Sleep; Sneezing; Substance Withdrawal Syndrome; Sweating; Sympathetic Nervous System; Symptoms; System; Temperature; Testing; Time; Toxic effect; Tremor; United States National Institutes of Health; Validation; Wireless Technology; Withdrawal; arm; base; biophysical properties; care costs; complex data; cost; experience; flexibility; handheld mobile device; human subject; improved; innovation; interest; machine learning algorithm; microchip; monitoring device; nanofabrication; neonatal care; neonate; neuromuscular activity; novel; opioid exposure; opioid withdrawal; phase 1 study; phase 2 study; prenatal exposure; printed circuit board; real time monitoring; response; sensor; therapy duration; tool; treatment response; treatment risk; wearable device; wearable sensor technology

SPECIFIC AIMS 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. 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. 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. 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 NAS. 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 interlinked, infant-targeted wearable biosensor-systems capable of continuously monitoring the biochemical to biophysical parameters of opioid-dependent neonates under treatment for NAS. Our team has outstanding experience in all areas necessary to this investigation. 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.

具体目标 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， 子宫暴露的新生儿。NAS的成本很高：患有NAS的新生儿通常在新生儿护理中心接受护理。 重症监护室（NICU），每天的护理费用很高。近22，000名婴儿出生时患有NAS， 一年花费15亿美元。此外，用于治疗NAS的基于药物的干预措施， 80%的阿片类药物暴露的婴儿，有自己的毒性和药物相互作用的风险。尽管有医疗费用， NAS的高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 并遭受考官偏见的困扰迫切需要创新的新方法来诊断NAS， 评估治疗反应的有效性。 灵活、低成本的可穿戴设备（戴在皮肤上），可以报告全身生化指标， 生物力学方法提供了一种简单且经济的解决方案。在NAS中，交感神经系统的波动 活动产生心率增加、皮肤电导、体温不稳定和震颤。这些表现在 增加婴儿出汗，癫痫发作，震颤，体温不稳定，和更多的事件，必须 由护士持续监测和评估。无监督的、客观的检测/量化身体 对患有NAS的新生儿的反应可能会推动新的客观评分工具的开发， 指导NAS治疗的开始、强度和持续时间。这些工具可以大大减少医疗费用 通过减少患者在NICU的时间，减少护士工作量，改善门诊服务， 监测，并帮助帮助优化患者治疗。关键是，我们认为这样的工具可能 能够客观地捕捉护士或婴儿睡眠时可能未注意到的事件（轻微 震颤、氧合不良、温度波动、脱水）。 该提案旨在开发相互关联的、针对婴儿的可穿戴生物传感器系统， 监测接受NAS治疗的阿片类药物依赖新生儿的生物化学至生物物理参数。 我们的团队在调查所需的所有领域都有出色的经验。我们的业务部门拥有 在可穿戴生物传感、检测交感神经系统活动方面， 阿片类药物戒断、儿科、商业发展和知识产权。我们的学术合作伙伴有 在新型生物传感器开发方面具有丰富的经验。