Commercialization of a Monitor to Assess Neurological Health in Neonates

DESCRIPTION (provided by applicant): Unlike adults, neonates cannot undergo traditional mental status testing (orientation, language, memory, etc.) as a measure of cortical function. However, the use of EEG is well established as one of the only semi-objective means to characterize the health of the cerebral cortex in neonates. Unfortunately, the availability of expert neonatal EEG interpretation is very limited, and is present at relatively few specialized pediatric centers in the country. Even when available, the review and interpretation of neonatal EEG is time and labor intensive. Because of these limiting factors, many hospitals rarely perform EEG monitoring in the neonatal intensive care unit, regardless of its value in neurological assessment. The envisioned device from this project is an EEG monitor that can trend the neurological wellness of neonates, with the capability for complete EEG review and verification by clinicians. The algorithm being developed for this monitor specifically analyzes neonatal EEG for clearly defined abnormalities in order to provide a simple neurological assessment score (the N3 Index) in one of the following ranges: (i) normal, (ii) mildly abnormal, (iii) moderately abnormal, or (iv) severely abnormal. The assessment algorithm consists of signal processing techniques used to quantify the amplitudes, durations, and frequency compositions of any discontinuities or asymmetries present in neonatal EEGs. The algorithm also includes methods for artifact effect minimization and the discrimination of foreground events from the background EEG. A data fusion analysis of the selected signal processing parameters calculates the final assessment score, which is displayed over time to produce a reliable trend of EEG assessment. More accurate prognoses of neurologically at-risk newborns from the proposed monitor may have several benefits. First, they can impact level of care decisions, especially for those neonates given poor prognoses (e.g.: severe neurological deficits or death). Secondly, the continuous assessment of the EEG background can be a measure of treatment success, indicating neurological improvement or decline after treatment has been given. The relevance of the proposed project is that the development of an easy-to-use neonatal EEG monitor with accurate analysis methods could enable more widespread monitoring of brain status in newborns. It also would enable earlier detection and management of brain injury in this population, which could promote both improved outcomes and reduced health care costs.