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: 10661085
• 负责人: Shiva Sharareh
• 金额: $ 128.48万
• 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 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10661085
• 关键词: Accelerometer; Acoustics; Adult; Agreement; Algorithms; Ambulatory Monitoring; Area; Artificial Intelligence platform; Behavioral; Biochemical; Biomechanics; Biosensing Techniques; Biosensor; Birth; Body Temperature; Businesses; California; Caregivers; Caring; Charge; Child; Classification; Clinical; Clinical Trials; Collaborations; Commercial grade; Crying; Data; Data Analytics; Dehydration; Detection; Development; Devices; Diagnosis; Drug Interactions; Eating; Event; Family; Funding; Galvanic Skin Response; Health; Health Personnel; Health Professional; Heart Rate; Hospital Costs; Hospitals; Image; Infant; Innovation Corps; Intellectual Property; Intervention; Interview; Investigation; Israel; Length of Stay; Marketing; Measures; Mechanics; Medical Care Costs; Medical center; Methods; Minor; Monitor; Motion; Multicenter Studies; Muscle; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Newborn Infant; Nurses; Nursing Assessment; Opiate Addiction; Oxygen; Patient-Focused Outcomes; Patients; Pediatric Hospitals; Pediatrics; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Physician Executives; Physiological; Procedures; Process; Production; Pulse Oximetry; Reporting; Risk; Running; Sales; Seizures; Services; Severities; Skin; Sleep; Substance Withdrawal Syndrome; Sweating; Sympathetic Nervous System; Symptoms; System; Tablets; Temperature; Testing; Time; Toxic effect; Tremor; United States; United States National Institutes of Health; Universities; Validation; Withdrawal; biophysical properties; care costs; commercialization; cost; deep learning; digital; digital assessment; efficacy evaluation; experience; flexibility; handheld mobile device; improved; innovation; interest; machine learning model; monitoring device; neonatal care; neonate; novel; opioid exposure; opioid withdrawal; patient portal; prenatal exposure; programs; prototype; psychologic; real time monitoring; response; safety assessment; sensor; standard of care; success; therapy duration; tool; treatment response; treatment risk; verification and validation; visual learning; wearable device; wearable monitor; wearable sensor technology; web services; wireless

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.

项目概要 新生儿戒断综合症（NAS）是一种阿片类药物戒断综合症，在出生后不久发生 子宫暴露的新生儿。 NAS 的费用很高：患有 NAS 的新生儿通常在新生儿科接受护理 重症监护病房（NICU），日常护理费用很高。近 22,000 名婴儿出生时均患有 NAS 每年花费 15 亿美元1。此外，用于治疗 NAS 的基于药物的干预措施已用于多达 80% 接触阿片类药物的婴儿都有自己的毒性和药物相互作用的风险 2. 尽管医疗费用很高， 由于 NAS 具有较高的社会影响以及治疗的风险，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 评估治疗反应的功效。 灵活、低成本的可穿戴设备（戴在皮肤上），可以报告全身生化和 生物力学过程提供了一种简单且经济的解决方案。在 NAS 中，交感神经系统激增 活动会导致心率加快、皮肤电导、体温不稳定和颤抖。这些体现在 婴儿出汗增多、癫痫发作、颤抖、体温不稳定等等——必须发生的事件 由护士持续监测和评估。无监督、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评分工具的开发，这些工具可以 指导 NAS2 治疗的开始、强度和持续时间。这些工具可以显着减少医疗费用 通过减少新生儿重症监护病房 (NICU) 的患者时间、减少护士负担、改善门诊情况，降低成本并改善患者治疗效果 监测，并帮助优化患者治疗。至关重要的是，我们相信这样的工具可以 能够客观地捕捉护士可能忽视的事件或婴儿睡觉时的事件（轻微的事件） 颤抖、氧合不良、温度波动、脱水）。 该提案旨在开发、评估和商业化互连的、针对婴儿的可穿戴生物传感器 能够自动数字评分的系统，持续监测生化、心理和 阿片类药物依赖新生儿的环境到生物物理参数，同时提供建议性治疗 NAS。我们的团队和合作伙伴在本次调查开展所需的所有领域都拥有出色的经验 商业级可穿戴腕带监控套件，包括：(1) 婴儿可穿戴腕带，(2) 成像 相机 (3) 充电站、(4) 平板电脑应用程序和 (5) 为专业医疗保健提供者量身定制的患者门户。 我们的业务部门在可穿戴生物传感、交感神经系统检测方面拥有 NIH 资助的丰富经验 阿片类药物戒断、儿科、商业发展和知识产权中的神经系统活动。我们的 学术合作伙伴在新型生物传感器开发方面拥有丰富的经验。