Neonatal Neurological Monitor (N2M)
Department of Health and Human Services
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Small Business Information
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
INFINITE BIOMEDICAL TECHNOLOGIES, LLC, 3600 CLIPPER MILL ROAD #410, BALTIMORE, MD, 21211
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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.
* information listed above is at the time of submission.