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 新生儿禁欲综合征（NAS）是一种阿片类药物戒断综合征，在出生后不久就会发展 子宫暴露的新生儿。 NAS的成本很高：NAS的新生儿通常在新生儿接受护理 重症监护室（NICU），那里的日常护理费用很高。近22,000名婴儿有NAS 一年，成本为15亿美元。此外，基于药物治疗的NAS的干预措施用于 80％的暴露于阿片类药物的婴儿具有自身的毒性和药物相互作用的风险。尽管有医疗费用， NAS的高社会影响以及治疗的风险，评估NAS严重性的工具可能是主观的 并患有审查员偏见。迫切需要创新的新方法来诊断NAS和 评估对治疗反应的效率。 可以报​​告全身生化和 生物力学过程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 活动产生增加心率，皮肤电导，不稳定的温度和震颤。这些体现在 婴儿出汗，癫痫发作，震颤，体温不稳定等增加 - 必须 由护士不断监控和评估。身体的无监督，客观检测/定量 遭受NAS的新生儿的反应可能会推动开发新的，客观的评分工具，这些工具可以 指导NAS疗法的启动，强度和持续时间。这样的工具可以大大减少医疗 成本并通过减少NICU的患者时间，减少护士负荷，改善门诊，改善患者的预后 监测，并有助于帮助优化患者治疗。至关重要的是，我们认为这样的工具可能 能够客观地捕获可能不会被护士或婴儿睡觉时注意到的事件（次要 震颤，氧合不足，温度波动，脱水）。 该建议旨在开发相互联系的，靶向婴儿的可穿戴生物传感器系统，能够连续 监测NAS治疗中阿片类药物依赖性新生儿的生物物理参数。 我们的团队在这项投资所需的所有领域都有出色的经验。我们的业务部门有 在发现交感神经系统活动中，大量的NIH资助了可穿戴生物传感的经验 在阿片类药物戒断，儿科，业务发展和知识产权中。我们的学术伙伴有 新型生物传感器开发方面的广泛经验。