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

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，被称为新生儿阿片戒断综合征(NOWS)，也被称为新生儿禁欲 综合征(NAS)。在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学护理。不幸的是， 非药理学护理(包裹、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 采用随机振动触觉刺激(SVS)技术的医院摇篮垫的安全性和有效性 一种辅助的非药物治疗，以改善NOWS婴儿的护理。在第一阶段，我们 证明了技术上的可行性，复制了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。我们论证了引进该装置的商业可行性。 对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附件或更换 非药理捆绑包。在这个项目中，FDA拒绝了PRapela的许可申请 SVS医院摇篮垫与临床使用的原型垫之间的等效性的主要问题 与商业垫片和表面织物覆盖材料的非临床安全性的对比研究 生物相容性、清洁和消毒。为了克服FDA的非临床安全担忧，我们将开发 一种采用新表面织物材料的新衬垫覆盖物，然后通过FDA的生物兼容性要求， 清洁和消毒。为了解决FDA对原型PAD和新PAD之间等价性的担忧 商用垫我们将完成内部振动研究，表明同等性能。成功者 该项目的完成将提供用于向FDA提交的新数据，以获得商业化许可 我们的低成本、非药物设备，以改善NOWS新生儿的临床病程。

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.