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，称为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，平均 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。 建议作为初始疗程，必要时转为药物治疗。不幸的是， 非药物护理（襁褓、摇动、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）技术在我院使用安全性和有效性， 一种预防性的非药物治疗，以改善NOWS婴儿的护理。在第一阶段，我们 证明了技术可行性，复制了试验用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。我们证明了引入该设备的商业可行性 51名医疗保健专业人员，超过70%的人表示他们将使用该设备作为辅助或替代 非药物束。在这个项目中，FDA拒绝了Prapela的许可申请， SVS hospital呼吸垫，主要关注临床使用的原型呼吸垫之间的等同性 研究对比市售衬垫和表面织物覆盖材料的非临床安全性 生物相容性、清洁和消毒。为了克服FDA的非临床安全问题，我们将开发 一种新的衬垫覆盖物，具有新的表面织物材料，然后通过FDA的生物相容性要求， 清洁和消毒。为了解决FDA对原型衬垫与新衬垫之间等效性的担忧， 我们将完成内部振动研究，表明性能相当。成功 该项目的完成将提供数据，用于向FDA提交的新申请，以获得商业化批准 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) requires 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, and efficacy 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 I, 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 the commercial feasibility of 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. During this project, the FDA rejected Prapela’s application for clearance of the SVS hospital bassinet pad with primary concerns of equivalence between a prototype pad used in the clinical study versus the commercial pad and the non-clinical safety of the surface fabric cover material relative to biocompatibility, cleaning and disinfection. To overcome the FDA’s non-clinical safety concerns, we will develop a new pad cover with a new surface fabric material and then pass FDA requirements for biocompatibility, cleaning, and disinfection. To address the FDA concerns of equivalence between the prototype pad and the new commercial pad we will complete in-house vibration studies indicating equivalent performance. The successful completion of the project will provide data for use in a new submission to the FDA for clearance to commercialize our low-cost, non-pharmacological device to improve the clinical course of newborns with NOWS.