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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。

基本信息

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
项目类别：
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

项目摘要

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.

项目总结