Neonatal EEG MOnitor (NEMO) Phase IIb

新生儿脑电图监测仪 (NEMO) IIb 期

• 批准号: 10699865
• 负责人: Neil J McDonald
• 金额: $ 99.99万
• 依托单位: QUASAR, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699865
• 关键词: Adult; Applied Research; Businesses; Child; Clinical; Collaborations; Data; Development; Devices; Documentation; Dryness; Early Diagnosis; Early treatment; Electrodes; Electroencephalography; Electromagnetics; Electronics; Environment; Epilepsy; Evaluation; Feedback; Funding; Gel; Goals; Good Manufacturing Process; Hospitals; Hour; Human; Hygiene; Infant; Intellectual functioning disability; Length of Stay; Manufacturer; Marketing; Medical; Medical Device; Monitor; Morbidity - disease rate; Neonatal; Neonatal Intensive Care Units; Neurodevelopmental Disability; Newborn Infant; Pediatric Hospitals; Performance; Personal Satisfaction; Phase; Positioning Attribute; Protocols documentation; Risk; Safety; Seizures; Signal Transduction; Skin; Skin injury; Small Business Innovation Research Grant; Specific qualifier value; System; Testing; Time; United States National Institutes of Health; Validation; Work; biomaterial compatibility; commercial launch; commercialization; design; follow-up; improved outcome; innovation; manufacturability; manufacture; monitoring device; mortality; neonatal seizure; neonate; nervous system disorder; pandemic disease; pressure; prototype; quantum; safety testing; sensor; sensor technology; skills; skin damage; usability

Abstract Neonatal seizures occur in over 14,000 newborns annually in the US, and are frequently associated with long-term deleterious consequences including intellectual disability, epilepsy, and other neurodevelopmental disabilities. Electroencephalography (EEG) is the only reliable means of detecting seizures; however, many Neonatal Intensive Care Units (NICUs) do not have the capability to do EEG recordings due to the lack of skilled EEG technicians to apply gel- based electrodes to delicate neonatal skin and acquire clean signals. Under NIH SBIR funding, Quantum Applied Science and Research (QUASAR), a leader in noninvasive sensor technology, in collaboration with Children’s National Hospital (CNH), a top ranked pediatric hospital, has been developing a Neonatal EEG MOnitor (“NEMO”) device intended as a reliable and easy-to-use EEG system that will increase availability of neonatal EEG monitoring to hospitals that typically lack this capability. The NEMO device takes advantage of QUASAR’s innovative dry sensing technology combined with a soft cap that is designed for minimal impact on the infants’ wellbeing and ease of use in the hospital environment. NEMO will lead to more neonates being screened and treated, and thus to shorter hospital stays and improved outcomes. Under Phase I and Phase II of this project, QUASAR and CNH have validated QUASAR’s dry electrodes for the neonatal monitoring application in a NICU environment, demonstrating their signal quality was comparable to that of wet electrodes, and built a prototype NEMO headset. The main goal of the proposed Phase IIb effort is to finalize the NEMO device, validate its performance on neonates in the NICU environment, and obtain 510(k) clearance for it. In order to accomplish this goal, QUASAR will work with ProPharma, a regulatory consultant firm, to establish current Good Manufacturing Practices (cGMP) and finalize the NEMO device under cGMP. QUASAR will then complete Safety Testing, and in collaboration with CNH will conduct a Clinical Validation to obtain the necessary data for a 510(k) submission. The final step in the project will be a product launch in partnership with medical device manufacturers and distributors.

抽象的 新生儿癫痫发作每年在美国每年有14,000多名新生儿发生，并且经常是 与长期有害后果有关，包括智力残疾，癫痫， 和其他神经发育障碍。脑电图（EEG）是唯一可靠的 检测癫痫发作的手段；但是，许多新生儿重症监护病房（NICUS）没有 由于缺乏熟练的脑电图技术人员应用凝胶 - 基于微妙的新生儿皮肤并获得清洁信号的电极。 根据NIH SBIR资助，量子应用科学与研究（Quasar）， 非侵入性传感器技术与儿童国家医院（CNH）合作， 排名的小儿医院一直在开发新生儿脑电图监测器（“ Nemo”）设备 旨在作为可靠且易于使用的脑电图系统，将增加新生儿的可用性 脑电图对通常缺乏这种能力的医院进行监测。 Nemo设备采用 类星体创新的干燥灵敏度技术的优势与软帽相结合 专为对婴儿的福祉和医院易用性而设计 环境。 Nemo将导致更多的新生儿被筛选和处理，从而较短 住院并改善结果。 在该项目的第一阶段和第二阶段，Quasar和CNH已验证了类星体的干燥 NICU环境中新生儿监测应用的电极，证明其 信号质量与湿电极的信号质量相当，并建立了原型NEMO耳机。 拟议的IIB阶段工作的主要目标是确定NEMO设备，验证其 在NICU环境中的新生儿的性能，并为其获得510（k）的清除。为了 为了实现这一目标，Quasar将与监管顾问公司Propharma合作 建立当前的良好制造实践（CGMP），并在下面确定NEMO设备 CGMP。然后，Quasar将完成安全测试，并与CNH合作进行 临床验证以获取510（k）提交的必要数据。最后一步 项目将与医疗设备制造商合作推出产品 分销商。

项目成果

Evaluation of Dry Sensors for Neonatal EEG Recordings.

• DOI: 10.1097/wnp.0000000000000237
• 发表时间: 2016-04
• 期刊: Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society
• 作者: Fridman I;Cordeiro M;Rais-Bahrami K;McDonald NJ;Reese JJ Jr;Massaro AN;Conry JA;Chang T;Soussou W;Tsuchida TN
• 通讯作者: Tsuchida TN