Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome.

Prapela™ SVS：一种经济高效的随机振动触觉刺激装置，可改善患有新生儿戒断综合征的婴儿的临床过程。

• 批准号: 10259507
• 负责人: John Phillip Konsin
• 金额: $ 133.06万
• 依托单位: PRAPELA, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-06-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259507
• 关键词: Academy; Acute; Admission activity; American; Birth; Breathing; Caregivers; Caring; Clinical; Clinical Research; Coronavirus; Crying; Data; Devices; Diagnosis; Disadvantaged; Discipline of Nursing; Electromagnetics; Epidemic; Family; Future; Grant; Health Professional; Heart Rate; Home; Hospitalization; Hospitals; Hour; Human; Human Resources; Incidence; Infant; Infant Care; Interview; Investigation; Kentucky; Length of Stay; Light; Marketing; Masks; Mattresses; Measurement; Measures; Medicaid; Medical Care Costs; Medical Device; Methods; Monitor; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Newborn Infant; Ohio; Opioid; Outcome; Outcome Measure; Overdose; Parents; Patients; Pediatrics; Perception; Perinatal; Pharmacological Treatment; Pharmacology; Phase; Pregnancy; Protocols documentation; Reporting; Research; Resolution; Resources; Safety; Scoring Method; Seizures; Severities; Skin; Sleep; Sleep Wake Cycle; Sleep disturbances; Small Business Innovation Research Grant; Symptoms; Technology; Temperature; Testing; Time; Training; Tremor; Video Recording; Woman; Work; addiction; base; biomaterial compatibility; commercialization; consumer product; cost; cost effective; drug withdrawal; efficacy testing; experience; improved; improved outcome; innovation; interest; men; morphine equivalent; neonatal care; opioid epidemic; opioid use disorder; pregnant; preservation; primary outcome; programs; public health emergency; sound; vibrotactile stimulation

Project Summary/Abstract Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold with an average hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs (Strahan, 2019). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment moving to pharmacological care when required. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources (Theilking, 2017). To reduce the increasing burden on limited resources, the evidence emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish the safety, efficacy, and acceptability of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS) technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. In phase one, we demonstrated technical feasibility, replicating the clinically critical stimulation of an investigational device reported to significantly reduce hyperirritability and pathophysiological instabilities without altering sleep states in NOW infants at a cost below $250/unit. We demonstrated commercial feasibility introducing the device to 51 healthcare professionals with over 70% indicating they would use the device as an adjunct to or replace non- pharmacological bundles. To accomplish the objective, we plan to execute the following specific aims; 1) determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS. Efficacy will be established through a clinical study with NOWS infants who have reached severity criteria for pharmacological treatment using the modified Finnegan scoring method. Cardio-respiratory monitoring will capture measurements allowing comparison of periods when SVS is on or off. With each infant serving as its own control, the primary outcome measure will be the stability of cardiorespiratory control. In addition to non- clinical product testing, safety will be demonstrated by scoring sleep state durations with a masked trained reviewer of high-resolution video recordings. A change of 20% in the duration of quiet sleep when SVS is on compared to off will be considered significant. Acceptability will be assessed with interviews completed by clinical staff and parents measuring their perceptions on ease of use, infant comfort, and interest in future use of the device. The successful completion of the project will provide data to support FDA clearance for commercialization of our low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.

项目摘要/摘要 母亲对阿片类药物的使用和成瘾导致#年戒毒并发症史无前例地上升 新生儿称为新生儿阿片类药物戒断综合征(NOWS)，也称为新生儿禁欲 综合征(NAS)。2004至2016年间，NOWS的招生人数增加了四倍多，平均 住院天数(15.9天比4.98天)几乎是非NOWS患者的3.2倍 导致年度成本飙升至近5.73亿美元，其中83%归因于州医疗补助计划 (Strahan，2019年)。虽然治疗NAS没有被接受的标准，但非药物捆绑包是 建议作为初始疗程，在需要时转移到药理护理。不幸的是， 非药物护理(婴儿、摇摆、频繁喂食和皮肤接触)需要大量使用 人力资源(Theilking，2017)。为了减轻对有限资源日益增加的负担，有证据表明 有消息称，医院正试图为消费者调整婴儿产品，而这些产品既不是预期的，也不是测试对象 用于NAS婴儿，作为其非药理捆绑的一部分。此应用程序的目标是建立 随机振动触觉刺激(SVS)摇篮垫的安全性、有效性和可接受性 技术作为一种辅助的非药物治疗，以改善NOWS婴儿的护理。同相 首先，我们证明了技术上的可行性，复制了一种研究设备的临床关键刺激 据报道，在不改变睡眠状态的情况下，显著减少过敏性和病理生理不稳定性 现在婴儿的价格低于250美元/台。我们论证了将该设备引入51的商业可行性。 超过70%的医疗保健专业人员表示，他们将使用该设备作为非 药理捆绑。为实现这一目标，我们计划实现以下具体目标：1) 确定SVS医院摇篮垫的有效性，2)证明SVS医院摇篮的安全性 PAD，以及3)评估临床工作人员和照顾NOWS婴儿的父母对该设备的接受程度。 疗效将通过对NOWS婴儿进行临床研究来确定，这些婴儿已经达到了严重的 采用改良的芬尼根评分法进行药物治疗。心肺功能监测将 捕获测量允许比较SVS打开或关闭的时间段。每个婴儿都充当着它的 自身控制，主要结果衡量标准将是心肺控制的稳定性。除了非- 临床产品测试，将通过对睡眠状态持续时间进行评分来证明安全性 高分辨率视频记录的审阅者。SVS开启时安静睡眠时长变化20% 与关闭相比，将被认为具有重大意义。可接受性将通过临床完成的访谈进行评估 工作人员和家长衡量他们对易用性、婴儿舒适性和未来使用兴趣的看法 设备。该项目的成功完成将为FDA批准商业化提供数据 我们的低成本、非药物设备，以改善NOWS新生儿的临床病程。