Neonatal Neurological Monitor - Regulatory Approval

描述(由申请人提供)：新生儿神经监测：监管部门批准的围产期窒息发生率为每1,000名活产儿中有2-4名，占全球每年500万新生儿死亡人数的19%。在了解疾病过程的病理生理学和研究潜在的神经保护策略方面已经做出了重大努力。生命的最初几个小时被确定为一个关键时期，在此期间干预具有改善结局的最佳潜力。然而，转化性研究和临床护理都受到缺乏客观验证的神经损伤实时床边评估工具的限制。为了满足这一需求，我们开发了一种新的基于多参数EEG的指数，该指数将频谱分析和时间分析结合到神经损伤的统一测量中。这一指标在仔猪模型中进行了评估。调整后的算法显示了90%和95%的敏感度和特异度来识别组织病理学定义的不良结果。然后，我们使用围产期窒息后NICU的脑电记录来评估该指数。使用盲人专家对信号的视觉解释以及Sarnat评分作为基准。建立了一系列接收器-算子曲线，在所有情况下，优化算法的灵敏度和特异度均保持在80%以上。我们现在打算继续进行第二阶段的竞争，目标只有一个：通过CHI/B分析，获得FDA批准无限公司的I-2020 EEG系统。为了获得必要的数据来支持我们期望的标记用于脑病新生儿的评估，我们将进行一项临床研究。这将检验两个假设：1)在监测的第一个小时内，该指数可以比目前任何其他可用的测量方法更灵敏和准确地评估出生7天时核磁共振所定义的神经损伤的严重程度；以及2)在生命第一天测量的指数可以评估神经发育结果。如果我们成功了，合成的设备将能够对患者进行分层，进行神经保护研究，并最终确定哪些患者将从治疗中受益。此外，应该指出的是，拟议的监控器将是第一个获得监管部门批准的此类标签。这个单一的终点定义了项目的成功完成。神经保护是治疗围产期窒息的一种新兴疗法。然而，早期识别可以从神经保护治疗中受益的患者是有限的。该项目旨在使FDA批准一种基于脑电的监测系统，该系统可以作为临床研究工具，进一步加强对围产期窒息后新生儿的诊断评估。

DESCRIPTION (provided by applicant): Neonatal Neurological Monitor: Regulatory Approval Perinatal asphyxia occurs in 2 - 4 per 1,000 live term newborns, and is responsible for 19% of the 5 million neonatal deaths per year worldwide. Significant effort has gone into understanding the pathophysiology of the disease process and to investigate potential neuroprotection strategies. The first hours of life have been identified as a critical period during which intervention has the best potential for improving outcome. However, both translational research and clinical care have been limited by the lack of an objective validated tool for real-time bedside evaluation of neurological injury. To address this need, we developed a novel multi-parametric EEG-based index which incorporates both spectral and temporal analysis into a unified measure of neurological injury. This index was evaluated in a piglet model. The tuned algorithm demonstrated a sensitivity and specificity of 90% and 95% respectively to identify poor outcome as defined by histopathology. We then evaluated the index using EEG recordings from the NICU following perinatal asphyxia. Visual interpretation of the signal by a blinded expert as well as the Sarnat score were used as benchmarks. A series of receiver- operator curves were created, and the sensitivity and specificity of the tuned algorithm remained above 80% in all cases. We now intend to pursue a Phase II competing continuation with a single aim: To obtain FDA clearance for Infinite's I-2020 EEG system with CHI/b analysis. To obtain the data needed to support our desired labeling for use in the assessment of encephalopathic newborns, we will undertake a clinical study. This will test two hypotheses: 1) within the 1st hour of monitoring, the index can assess the severity of neurological injury as defined by the MRI at 7 days of life with greater sensitivity and accuracy than any other currently available measure; and 2) the index measured during the 1st day of life can assess neurodevelopmental outcome. If we are successful, the resultant device will enable stratification of patients for neuroprotection studies as well as for eventual identification of patients who would benefit from therapy. Additionally, it should be noted the proposed monitor will be the first with regulatory clearance for such labeling. This singular endpoint defines successful completion of the project. Neuroprotection is an emerging therapy for treating perinatal asphyxia. However, early identification of patients which can benefit from neuroprotective treatment is limited. This project aims to achieve FDA approval of an EEG based monitoring system that can serve as a clinical research tool to further enhance diagnostic evaluation of neonates post perinatal asphyxia.