Neonatal Neurological Monitor (N2M)

描述（由申请人提供）：围产期窒息是大多数儿童非进行性神经功能障碍的原因。在了解疾病过程的病理生理学和研究潜在的治疗方法方面已经付出了巨大的努力。然而，评估婴儿对神经损伤的进化反应仍然是一个床边的挑战。因此，我们着手开发新生儿神经监护仪（N2M）。我们的第一阶段工作重点是开发两个定量脑电图（qEEG）参数。我们评估了光谱和时间算法（分别为归一化分离NS和Teager能量算子TEO）。在猪围产期窒息模型中对该技术进行了评估，窒息后1小时测量的NS和TEO与窒息后24小时测量的神经缺损评分（NDS）具有良好的相关性（NS < 0.02, TEO < 0.05）。该技术被封装在具有用户友好图形界面和触摸屏的Panel PC中。我们现在提出了一种新的脑损伤挥发性分析（VA）的统一测量方法，该方法旨在响应光谱和时间变化。因此，它将提供损伤电生理后遗症的单一定量描述。我们将在慢性猪分级损伤模型和新生儿重症监护病房的初步研究中测试所有三种算法（NS、TEO和VA），并进行12个月的神经发育随访。我们的长期目标是将N2M发展成为一种复杂的工具，为临床医生提供关于婴儿对皮质损伤不断变化的反应的持续反馈。

DESCRIPTION (provided by applicant): Perinatal asphyxia is responsible for the majority of non-progressive neurological deficits in children. Significant effort has gone into understanding the pathophysiology of the disease process and to investigate potential therapies. However, the assessment of the baby's evolving response to neurological injury remains a bedside challenge. Therefore, we embarked on a course to develop the Neonatal Neurological Monitor (N2M) Our Phase I effort focused on developing two quantitative EEG (qEEG) parameters. We evaluated both spectral and temporal algorithms (Normalized Separation, NS and the Teager Energy Operator, TEO respectively). The technology was evaluated in a porcine model of perinatal asphyxia NS and TEO measured at 1 hour post asphyxia were well correlated with the Neuro-Deficit Score (NDS) measured at 24-hours post asphyxia (p < 0 02 for NS and p < 0 05 for TEO). The technology was packaged into a Panel PC with a user-friendly graphical interface and a touch-sensitive screen. We now propose the development of a novel unifying measure of brain injury Volatility Analysis (VA) VA is designed to be responsive to both spectral and temporal changes. Thus, it will provide a singular quantitative description of the electrophysiological sequelae of injury. We will test all three algorithms (NS, TEO, and VA) in a chronic porcine model of graded injury and in a pilot study in the Neonatal Intensive Care Unit with 12-month neurodevelopmental follow-up. It is our long-term goal to develop the N2M as a sophisticated tool to provide continuous feedback to the clinician regarding the baby's evolving response to cortical injury.