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: 10408163
• 负责人: John Phillip Konsin
• 金额: $ 116.94万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10408163
• 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 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药物戒断综合征（现在），也称为新生儿禁欲 综合征（NAS）。在2004年至2016年之间，现在的入学率增加了四倍以上，平均 住院时间比非nows患者的住院时间近3.2倍（约15.9天，而4.98天） 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 建议在需要时作为最初的治疗方法移至药理护理。很遗憾， 非药理学护理（摇摆，摇摆，频繁喂养和皮肤接触）需要大量使用 人力资源（Theilking，2017年）。为了减轻有限资源的负担增加，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 带有随机纤维状刺激（SVS）的医院巴士板的安全性，功效和可接受性（SVS） 技术是一种辅助，非药物治疗，可改善现在的婴儿护理。在阶段 第一，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。我们证明了商业可行性将设备引入51 超过70％的医疗保健专业人员表明他们将使用该设备作为辅助手段或替代非 - 药理捆绑包。为了实现目标，我们计划执行以下特定目标； 1） 确定SVS医院巴斯纳特垫的功效，2）证明了SVS医院Bassinet的安全性 PAD和3）评估设备的可接受性，临床人员和父母照顾现在的婴儿。 疗效将通过临床研究确定，现在已经达到严重性标准的Nows婴儿 使用改良的Finnegan评分方法的药理治疗。心呼吸监测会 捕获测量值，可以比较SVS打开或关闭的时期。每个婴儿都用作 自身控制，主要的结果度量将是心肺控制的稳定性。除了非 临床产品测试，安全性将通过接受掩盖训练的睡眠状态持续时间来证明 高分辨率视频记录的评论者。当SVS开启时，安静的睡眠期间有20％的变化 与OFF相比将被认为是重要的。可接受性将通过临床完成的访谈评估 员工和父母衡量他们对易用性，婴儿舒适的看法，以及对未来使用的兴趣 设备。该项目的成功完成将提供数据以支持FDA许可以进行商业化 我们的低成本，非药理装置，以改善新生儿的临床过程。