Neonatal EEG Monitor (NEMO)

 描述(申请人提供)：新生儿癫痫是新生儿重症监护病房(NICU)常见的神经学诊断，每年在美国约有14,000名新生儿发生，并经常与包括智力残疾、脑瘫、癫痫和其他神经发育障碍在内的长期有害后果有关。及早发现和治疗可更有效地控制癫痫发作，降低癫痫发生率，还可减少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的唯一可靠手段是脑电记录。然而，许多NICU没有能力进行EEG记录，主要是因为缺乏熟练的EEG技术人员，需要将EEG常规湿电极应用于脆弱的新生儿皮肤。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监测(NEMO)系统，旨在成为一个可靠且易于使用的脑电系统，将增加对新生儿脑电监测的全天候可用性，并提供给通常缺乏这一能力的医院。NEMO利用Quasar的创新干式传感器技术，该技术已被证明可以记录高保真EEG信号，这些信号不受电子伪影的影响，不需要皮肤磨损或使用导电凝胶。这些干燥传感器被嵌入快速应用的耳机中，该耳机对新生儿皮肤温和，可由护理人员使用，导致更多有癫痫风险的新生儿得到快速筛查和适当治疗，这反过来有望缩短住院时间并改善预后。在这项SBIR的第一阶段下，新生儿的脑电在NICU中使用原型干式传感器成功地记录下来。干式传感器EEG信号与湿电极记录的EEG信号相当，被认为适合于临床相关的EEG模式的诊断。这些令人鼓舞的结果使我们在第二阶段的提案中进一步追求NEMO的发展。第二阶段工作的主要目标是将NEMO开发到准备向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.