Neonatal EEG Monitor (NEMO)

 描述（由申请人提供）：新生儿癫痫发作是新生儿重症监护室（NICU）中常见的神经病学诊断，在美国每年约有14，000名新生儿发生，并且经常与长期有害后果相关，包括智力残疾、脑瘫、癫痫和其他神经发育障碍。早期发现和治疗可以更有效地控制癫痫发作，降低癫痫发病率，还可以降低新生儿癫痫发作后的发病率和死亡率。检测和治疗新生儿癫痫发作的唯一可靠手段是脑电图记录。然而，许多NICU不具有进行EEG记录的能力，主要是由于缺乏将EEG常规湿电极应用于脆弱的新生儿皮肤所需的熟练EEG技术人员。QUASAR与儿童国家卫生系统（CNHS）合作，提议开发一种创新的新生儿脑电图监测（NEMO）系统，该系统旨在作为一种可靠且易于使用的脑电图系统，将增加一天中所有时间的新生儿脑电图监测的可用性，并提供给通常缺乏这种能力的医院。NEMO利用QUASAR的创新干传感器技术，该技术已被证明可以记录高保真EEG信号，不受电伪影的影响，无需皮肤磨损或使用导电凝胶。这些干传感器嵌入到快速应用的头戴式耳机中，该耳机对新生儿皮肤温和，可由护理人员应用，从而使更多有癫痫发作风险的新生儿得到快速筛查和适当治疗，从而有望缩短住院时间并改善结果。在该SBIR的第1阶段部分中，在NICU中使用原型干传感器成功记录了新生儿的EEG。干传感器EEG信号与湿电极记录的信号相当，并被认为适用于诊断临床相关EEG模式。这些令人鼓舞的结果促使我们在第二阶段提案中进一步追求NEMO的发展。第2阶段工作的主要目标是将NEMO开发到准备好向FDA申请510（k）上市前批准的程度。

 DESCRIPTION (provided by applicant): Neonatal seizures are a common neurologic diagnosis in the Neonatal Intensive Care Unit (NICU), occurring in some 14,000 newborns annually in the US, and are frequently associated with long-term deleterious consequences including intellectual disability, cerebral palsy, epilepsy, and other neurodevelopmental disabilities. Early detection and treatment can result in more effective seizure control and decreased rates of epilepsy and may also lead to reduced morbidity and mortality after neonatal seizures. The only reliable means of detecting and treating neonatal seizures is EEG recording. However, many NICUs do not have the capability to conduct an EEG recording, principally due to a lack of skilled EEG technologists needed to apply EEG conventional wet electrodes to delicate neonatal skin. QUASAR, in collaboration with Children's National Health System (CNHS), proposes to develop an innovative Neonatal EEG MOnitor ("NEMO") system intended as a reliable and easy-to-use EEG system that will increase the availability of neonatal EEG monitoring at all hours of the day and to hospitals that typically lack this capability. NEMO leverages QUASAR's innovative dry sensor technology that has been demonstrated to record high fidelity EEG signals that are immune to electrical artifacts, without the need for skin abrasion or the use of conductive gels. These dry sensors are embedded into a rapidly applied headset that is gentle to neonatal skin and can be applied by nursing staff, leading to more neonates at risk for seizures being quickly screened and appropriately treated, which in turn is expected to shorten hospital stays and improve outcomes. Under the Phase 1 portion of this SBIR, EEG from neonates was successfully recorded in an NICU using prototype dry sensors. The dry sensor EEG signals were comparable to those recorded with wet electrodes and deemed suitable for diagnosis of clinically relevant EEG patterns. These encouraging results are leading us to further pursue the development of NEMO in this Phase 2 proposal. The principal goal of the Phase 2 effort is to develop NEMO to the point of readiness to apply to the FDA for 510(k) premarket approval.