Neonatal EEG Monitor

描述（由申请人提供）：脑电图（EEG）是新生儿重症监护病房（NICU）的重要工具，用于诊断癫痫发作和癫痫持续状态，并监测危重新生儿。由于以下几个原因，目前可用的脑电图仪器是不够的：(1)准备时间延长，由于新生儿头皮的脆弱性，再次使用是有问题的；(2)它不容易适应临床cae地点，没有经验丰富的脑电图技术人员；(3)它不能在门诊环境之前或期间立即执行，因此失去了关键的诊断时间；(4)vernix的存在阻碍了电阻电极的接触。需要额外的时间来消除和限制当前湿电极脑电图技术用于新生儿使用的实际和快速诊断有用性。更实用的新生儿脑电图系统可以帮助诊断和治疗新生儿癫痫发作，从而潜在地减少神经系统疾病或婴儿死亡率。本应用旨在通过开发一种便携式、无线、干传感器的新生儿脑电图监测系统来解决新生儿脑电图的挑战，该系统可以轻松、快速、准确地应用于各种环境，技术技能有限，无需患者皮肤准备，以协助脑电图临床诊断和治疗策略，在到达新生儿重症监护病房之前和住院期间。QUASAR是无创传感器技术的领导者，在第一阶段将与儿童国家医疗中心合作，研究这种设备的技术可行性。儿童国家医疗中心是一家拥有完善的新生儿神经病学综合项目和新生儿神经强化服务的领先医疗机构。QUASAR拥有先进的干式传感器EEG技术，其信号质量被认为与成人受试者的湿电极获得的信号质量相当。干式传感器的超高阻抗放大器应允许类似的性能，甚至通过蜡质的vernix存在于一些新生儿。该项目将验证使用类星体传感器记录新生儿可解释脑电图的能力，并将开发一种易于使用的结构的机械设计，以定位和保持传感器在新生儿身上的位置。该项目的成功将为新生儿重症监护室带来若干技术创新和方法解决方案，这将促进和帮助诊断和管理危重新生儿。

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.