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

项目总结/摘要 母亲使用和成瘾阿片类药物导致药物戒断并发症前所未有的上升， 新生儿阿片类戒断综合征（NOWS），也称为新生儿戒断 综合征（NAS）。从2004年到2016年，NOWS的入学人数增加了四倍多， 住院时间几乎是非NOWS患者的3.2倍（15.9住院日与4.98住院日） 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）。虽然没有治疗NAS的公认标准，但非药物捆绑治疗是可行的。 建议作为初始治疗过程，必要时转为药物治疗。不幸的是， 非药物护理（襁褓、摇晃、频繁喂食和皮肤接触）需要大量使用 人力资源（Theilking，2017）。为了减轻有限资源日益增加的负担， 医院正试图为消费者调整婴儿产品，这些产品既不是有意的，也不是经过测试的。 NAS婴儿中使用，作为其非药物组合的一部分。本申请的目的是建立 随机振动触觉刺激（SVS）在我院使用安全性、有效性和可接受性 技术作为一种预防性的非药物治疗，以改善NOWS婴儿的护理。同相 第一，我们证明了技术可行性，复制了研究器械的临床关键刺激 据报道，在不改变睡眠状态的情况下， 在NOW婴儿中，成本低于250美元/单位。我们证明了将该设备引入51 超过70%的医疗保健专业人员表示，他们将使用该器械作为辅助或替代非 药理束为了实现这一目标，我们计划执行以下具体目标：1） 确定SVS医院呼吸垫的有效性，2）证明SVS医院呼吸垫的安全性 垫，以及3）评估临床工作人员和护理NOWS婴儿的父母对器械的可接受性。 将通过对达到以下严重程度标准的NOWS婴儿进行的临床研究确定疗效： 使用改良的Finnegan评分法进行药物治疗。呼吸监测将 捕获测量，允许比较SVS打开或关闭时的周期。每一个婴儿都是 自身控制，主要结局指标将是心肺控制的稳定性。除了非- 临床产品测试，安全性将通过使用经过训练的盲法对睡眠状态持续时间进行评分来证明 高分辨率视频记录的评论家。当SVS开启时，安静睡眠持续时间变化20% 与off相比，将被认为是显著的。可接受性将通过临床医生完成的访谈进行评估。 工作人员和家长测量他们对易用性，婴儿舒适度和未来使用的兴趣的看法， 设备.该项目的成功完成将为支持FDA批准商业化提供数据 我们的低成本，非药物设备，以改善新生儿与NOWS的临床进程。

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.