Neonatal EEG Monitor

描述（由申请人提供）：脑电图（EEG）是新生儿重症监护室（NICU）的重要工具，用于诊断癫痫发作和癫痫持续状态以及监测危重新生儿。目前可用的EEG仪器由于以下原因而不充分：（1）由于新生儿头皮的脆弱性，准备时间延长，并且重新应用是有问题的，（2）它不容易适应于没有保留有经验的EEG技术人员的临床CAE部位，（3）它不可获得或不能在流动环境之前或期间立即执行，因此损失了关键的诊断时间，以及（4）胎脂的存在阻碍电阻性电极接触，需要额外的时间来去除，并且限制了当前用于新生儿的湿电极EEG技术的实用和快速诊断有用性。更实用的新生儿EEG系统可以帮助诊断和治疗新生儿癫痫发作，从而可能减少神经系统疾病或婴儿死亡率。本申请旨在通过开发一种便携式、无线、干传感器、新生儿EEG监测系统来应对新生儿EEG的挑战，该系统可以在技术技能有限且无需患者皮肤准备的情况下轻松、快速和准确地应用于各种环境，以在到达NICU之前和停留在NICU期间协助EEG临床诊断和治疗策略。在第一阶段的工作中，QUASAR，非侵入性传感器技术的领导者，将与儿童国家医疗中心合作，这是一家领先的医疗机构，拥有完善的综合新生儿神经病学计划和新生儿神经强化服务，以检查这种设备的技术可行性。QUASAR拥有先进的干传感器EEG技术，其信号质量被认为与成人受试者使用湿电极获得的信号质量相当。干传感器的超高阻抗放大器应允许类似的性能，即使通过蜡状胎脂存在于一些新生儿。该项目将验证使用QUASAR传感器记录新生儿可解释EEG的能力，并将开发易于使用的结构的机械设计，以将传感器定位和固定在新生儿身上。该项目的成功将为新生儿重症监护室带来几项技术创新和方法解决方案，这将促进和帮助危重新生儿的诊断和管理。 公共卫生相关性：QUASAR和儿童国家医疗中心将合作开发一种创新的、非侵入性的新生儿脑电图监测系统，使新生儿重症监护室能够在以前不可能的环境中记录脑电图，而无需经过培训的脑电图技术人员。这项技术将提高监测和治疗危重新生儿的能力，并可能有助于降低癫痫发作或其他神经系统疾病造成的婴儿死亡率。

DESCRIPTION (provided by applicant): Electroencephalography (EEG) is a crucial tool in Neonatal Intensive Care Units (NICU), where it is used to diagnose seizures and status epilepticus and to monitor critically ill neonates. Currently available EEG instrumentation is inadequate for a number of reasons: (1) preparation times are extended and re-application is problematic due to the fragility of the neonatal scalp, (2) it is not easily adapted to clinical cae sites that do not retain experienced EEG technicians, (3) it is not available or able to perform immediately preceding or during the ambulatory environment, thus losing critical diagnostic time, and (4) the presence of vernix impedes resistive electrode contact, requiring additional time to remove and limiting the practical and rapid diagnostic usefulness of current wet electrode EEG technology for neonatal use. More practical neonatal EEG systems can help diagnose and treat neonatal seizures and thus potentially reduce neurological disorders or infant mortality. This application aims to address the challenges of neonatal EEG by developing a portable, wireless, dry-sensor, neonatal EEG monitoring system that can be easily, rapidly, and accurately applied in a variety of environments with limited technical skill and without patient skin preparation to assist in EEG clinical diagnosis and treatment strategies prior to arrival at and during stays in the NICU. In this Phase I effort QUASAR, a leader in noninvasive sensor technology, will collaborate with Children's National Medical Center, a leading medical institution with a well established comprehensive Neonatal Neurology Program and Neonatal Neurointensive Service, to examine the technical feasibility of such a device. QUASAR has advanced dry-sensor EEG technology to the point that its signal quality is considered comparable to that obtained with wet electrodes on adult subjects. The ultra-high impedance amplifiers of the dry sensors should allow similar performance even through the waxy vernix present on some neonates. This project will verify the capability of recording interpretable EEG from neonates using QUASAR's sensor, and will develop mechanical designs for an easy-to-use structure to position and hold sensors in place on neonates. The success of this project will bring about several technological innovations and methodological solutions to the NICU that will facilitate and aid in the diagnosis and management of critically ill neonates. PUBLIC HEALTH RELEVANCE: QUASAR and Children's National Medical Center will collaborate to develop an innovative, noninvasive neonatal EEG monitoring system that will enable Neonatal Intensive Care Units to record EEG without the need for trained EEG technicians, in environments in which this was previously not possible. This technology will improve the ability to monitor and treat critically ill neonates, and potentially help reduce infan mortality from seizures or other neurological disorders.