Neonatal Neurological Monitor (N2M)

新生儿神经监护仪 (N2M)

• 批准号: 6650935
• 负责人: Ananth Natarajan
• 金额: $ 66.84万
• 依托单位: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-11 至 2006-02-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6650935
• 关键词: biomedical equipment development; brain electrical activity; brain injury; clinical research; electroencephalography; histochemistry /cytochemistry; human subject; infant human (0-1 year); longitudinal human study; monitoring device; outcomes research; swine

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.

描述（由申请人提供）：围产期窒息负责儿童中大多数非进行神经系统缺陷。 理解疾病过程的病理生理学并研究潜在疗法的巨大努力。但是，对婴儿对神经损伤的不断发展的反应的评估仍然是床边挑战。因此，我们着手开发一门课程来开发新生儿神经系统监测仪（N2M），我们的第一阶段工作着重于开发两个定量的脑电图（QEEG）参数。我们评估了光谱和时间算法（分别为归一化的分离，NS和Teager Energy操作员TEO）。在窒息后1小时测量的围产期窒息和TEO的猪模型中，对该技术进行了评估，与在窒息后24小时测得的神经缺陷评分（NDS）相关（NS的P <0 02，NS的P <0 02，TEO的P <05）。该技术被包装到带有用户友好的图形接口和触摸敏屏幕的面板PC中。 现在，我们提出了一种新型的统一度量的脑损伤波动率分析（VA）VA的统一度量，旨在对光谱和时间变化均反应。因此，它将提供对损伤的电生理后遗症的单数定量描述。我们将在分级损伤的慢性猪模型中测试所有三种算法（NS，TEO和VA），并在具有12个月神经发育随访的新生儿重症监护病房的试点研究中测试。我们的长期目标是开发N2M作为复杂的工具，向临床医生提供有关婴儿对皮质损伤的不断发展的反应的连续反馈。