Neonatal Neurological Monitor - Regulatory Approval
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 out
come. 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 w
hich 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 out
come 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 receive
r- 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 syst
em 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.
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