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: 10837421
• 负责人: John Phillip Konsin
• 金额: $ 13.74万
• 依托单位: PRAPELA, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10837421
• 关键词: Address; Admission activity; Breathing; Caregiver Burden; Caring; Clinical; Clinical Research; Crying; Data; Devices; Diagnosis; Disinfection; Family; Health Professional; Heart Rate; Hospitals; Human Resources; Infant; Infant Care; Length of Stay; Medicaid; Medical Care Costs; Medical Device; Neonatal Abstinence Syndrome; Newborn Infant; Opioid; Patients; Performance; Phase; Recommendation; Reporting; Resources; Safety; Seizures; Skin; Sleep; Surface; Symptoms; Technology; Testing; Textiles; Tremor; addiction; biomaterial compatibility; commercialization; consumer product; cost; cost effective; drug withdrawal; experience; improved; improved outcome; pharmacologic; programs; prototype; vibration; 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) 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.

项目摘要/摘要 孕产妇对阿片类药物的使用和成瘾导致药物戒断并发症的前所未有 新生儿，被称为新生儿阿片类戒断综合征（现在），也称为新生儿禁欲 综合征（NAS）。在2004年至2016年之间，现在的入学率增长了四倍以上，平均 住院时间比非nows患者的住院时间近3.2倍（约15.9天为4.98） 导致每年成本增加到近5.73亿美元，其中83％归因于州医疗补助计划 （Strahan，2019年）。虽然没有接受NAS的可接受的标准，但非药物束是 建议作为初始治疗过程，在需要时转到药物护理。很遗憾， 非药物护理（摇摆，摇摆，经常喂养和皮肤接触）需要大量使用 人力资源（Theilking，2017年）。为了减少有限资源的燃烧，证据 出现的是，医院正试图适应既不打算也不旨在测试的消费者的婴儿​​产品 在NAS婴儿中用作非药物束的一部分。该应用的目的是建立 我们的医院摇篮垫的安全性和效率，具有随机颤振刺激（SVS）技术为 一种辅助，非药物治疗，可改善NOW婴儿的护理。在第一阶段，我们 证明了技术可行性，复制了研究装置的临床关键刺激 据报道，无需改变睡眠状态，可显着降低过度训练性和病理生理不稳定性 现在，婴儿的费用低于$ 250/单位。我们证明了引入设备的商业可行性 对于51名医疗保健专业人员，超过70％的专业人员表示他们将使用该设备作为辅助或替换 非药理学捆绑包。在此项目中，FDA拒绝了Prapela的清理申请 SVS医院的贝丝垫，主要关注临床中使用的原型垫之间的等效性 研究与商业垫和表面织物覆盖材料的非临床安全性相对于 生物相容性，清洁和消毒。为了克服FDA的非临床安全问题，我们将发展 带有新的表面织物材料的新垫盖，然后通过FDA要求生物相容性， 清洁和消毒。解决FDA对原型垫与新的等效性的关注 商业垫我们将完成内部振动研究，表明表现等效性能。成功 该项目的完成将提供用于向FDA提交的新提交的数据以进行清算以商业化 我们的低成本，非药理装置，以改善NOWS的临床过程。