Prapela® SVS incubator pad: A cost-effective stochastic vibrotactile device to improve the clinical course of infants with apnea of prematurity.

Prapela® SVS 保温箱垫：一种经济高效的随机振动触觉设备，可改善早产儿呼吸暂停婴儿的临床病程。

• 批准号: 10576754
• 负责人: Namasivayam Ambalavanan
• 金额: $ 50.02万
• 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: 2023-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10576754
• 关键词: Address; Affect; Age; Apnea; Benefits and Risks; Breakthrough device; Breathing; Caffeine; Caring; Citrates; Clinical; Clinical Management; Clinical Research; Complementary therapies; Consensus; Continuous Positive Airway Pressure; Control Groups; Data; Development; Devices; Dimensions; Direct Costs; Documentation; Dose; Drops; Electromagnetics; Engineering; Enrollment; Event; Frequencies; Future; Gestational Age; Healthcare; Heart Rate; Hospitals; Human; Hypoxemia; Incubators; Infant; Infant Care; Intervention; Licensing; Manuals; Marketing; Masks; Mattresses; Medical Device; Morbidity - disease rate; Newborn Infant; Outcome; Outcome Measure; Patients; Pediatrics; Peer Review; Pharmacological Treatment; Phase; Positioning Attribute; Power Sources; Pregnancy; Premature Birth; Premature Infant; Publishing; Questionnaires; Randomized, Controlled Trials; Recommendation; Reference Standards; Regulatory Pathway; Reporting; Research; Risk; Risk-Benefit Assessment; Safety; Small Business Innovation Research Grant; Software Validation; System; Techniques; Technology; Testing; Theophylline; Time; Treatment Efficacy; United States; United States National Institutes of Health; Validation; biomaterial compatibility; care burden; clinical efficacy; clinical risk; clinically relevant; clinically significant; commercialization; cost effective; design; effective therapy; efficacy evaluation; experience; group intervention; improved; inclusion criteria; manufacturing cost; manufacturing facility; novel; performance tests; premature; preterm newborn; primary outcome; prototype; randomized, clinical trials; respiratory; safety testing; standard of care; supplemental oxygen; tactile stimulation; ventilation; vibration; vibrotactile stimulation

Prapela proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Defined as cessation of breathing for 20 seconds or longer or a shorter pause accompanied by hypoxemia, AOP is a major morbidity among preterm infants and a significant healthcare burden. AOP affects 70% of all early preterm births (<34 weeks gestational age) and nearly all at ≤ 28 weeks’ gestation. In the United States in 2020, the total annual direct costs associated with AOP exceeded $12 billion. While there is no consensus for treating AOP, common interventions include positional techniques, caffeine citrate, manual tactile stimulation, and supplemental oxygen for hypoxemia. Caffeine citrate is the first line of therapy as it decreases apneic episodes and reduces the need for assisted ventilation. At recommended doses, caffeine has been proven safe and effective. However, in the sole trial supporting its FDA clearance, a majority of newborns treated with caffeine citrate continued to experience apnea events. In 2015, a clinical study using a stochastic vibrotactile stimulation (SVS) investigational device reported a 50% reduction in the number of apnea events. Prapela exclusively licensed the SVS technology of the investigational device and has demonstrated technical feasibility replicating the clinically critical stimulation in prototype incubator pads. The broad objective of this SBIR Fast-Track application is to generate the data and documentation necessary for FDA marketing clearance of a novel device to reduce apnea events in preterm newborns. To accomplish this objective, Prapela proposes four Specific Aims: 1) complete development of the SVS incubator pad, 2) demonstrate the safety of the device, 3) determine the clinical efficacy of the SVS incubator pad as an adjunctive therapy to concurrent pharmacological treatment in newborns with AOP, and 4) document the benefit-risk assessment of the device from clinicians caring for AOP patients. Efficacy will be established through a masked, randomized clinical trial with newborns of <33 weeks gestational age, with postmenstrual age (PMA) of <38 weeks at the time of enrollment. The control group will receive standard therapy only with caffeine citrate and respiratory support and an inert SVS device, while the intervention group will receive standard therapy concurrent with the Prapela SVS device. The primary outcome measure will be the mean number of apnea events in the three days after study entry, with a reduction in apnea events of 30% or more considered clinically significant. Questionnaires administered at the end of each experimental period to the clinicians present on the final shift will capture the benefit-risk assessment. The successful completion of the project will provide the data and documentation necessary for FDA marketing clearance and commercialization of our SVS incubator pad as a purpose-built device to improve clinical outcomes of preterm infants with AOP.

Prapela提议完成了新型医院孵化器PAD的安全，有效性和临床风险/益处的开发，该培养基垫将提供完整的治疗方法，并在20多年内对早产呼吸暂停（AOP）的临床管理进行首次改进。 AOP被定义为停止呼吸20秒或更长时间或较短的停顿，伴有低氧血症，AOP是早产儿的主要发病率，也是重大的医疗保健负担。 AOP影响了所有早期出生的70％（胎龄<34周），几乎全部≤28周的妊娠。在2020年美国，与AOP相关的年度直接成本超过120亿美元。尽管没有共识来治疗AOP，但常见的干预措施包括位置技术，柠檬酸咖啡因，手动触觉刺激以及缺氧的补充氧气。咖啡因柠檬酸含量是第一道治疗，因为它减少了呼吸暂停发作并减少了辅助通风的需求。以建议的剂量，咖啡因已被证明是安全有效的。但是，在支持其FDA清除率的唯一试验中，大多数用柠檬酸咖啡因治疗的新生儿继续经历呼吸暂停事件。 2015年，一项使用随机振动刺激（SVS）研究装置的临床研究报告，呼吸暂停事件数量减少了50％。 Prapela专门获得了研究设备的SVS技术，并且已经证明了技术可行性，可以复制原型孵化器垫中临床关键刺激。该SBIR快速轨道应用程序的广泛目标是生成FDA营销清除新颖设备所需的数据和文档，以减少早产新生儿中的呼吸暂停事件。为了实现这一目标，Prapela提出了四个具体目的：1）SVS孵化器垫的完全开发，2）证明设备的安全性，3）确定SVS孵化器垫作为辅助治疗的临床效率，作为一种辅助治疗，以同时使用AOP的药物治疗，并记录AP的新生儿，以及4）对设备的好处评估临时性的临床评估。疗效将通过一项掩盖的随机临床试验确定，新生儿胎龄<33周，并且在入学时的月经后年龄（PMA）<38周。对照组仅使用柠檬酸咖啡因和呼吸支持以及惰性SVS设备接受标准疗法，而干预组将与Prapela SVS设备同时进行标准疗法。主要结局指标将是研究进入后三天的平均呼吸暂停事件数量，呼吸暂停事件减少了30％或更高的临床意义。在最终轮班上存在的临床医生的每个实验期结束时，调查表将捕获利益风险评估。该项目的成功完成将为我们的SVS孵化器垫作为FDA营销批准和商业化所需的数据和文档，作为一种专门建造的设备，以改善AOP的早产儿的临床结果。