ADVANCED MEDICAL ELECTRONICS CORP — Department of Health and Human Services SBIR Phase II: NICHD

Description

Project Summary Abstract The goal of this project is to develop a portable low cost tool to aid in the diagnosis and management of neonates born with neurologic complications The project will develop instrumentation technology and associated software to enable early detection of neurologic brain injury and seizure activity for newborns delivered in care facilities that lack a full suite of neurological diagnostic tools In neonates with birth asphyxia seizures are very common and most frequently subclinical Many studies have observed that even experienced clinicians have difficulty correctly identifying seizures in this population Subsequently clinical paroxysms that do not truly represent seizure are frequently over treated and subclinical seizures including status epilepticus go unrecognized and untreated As such the use of continuous video electroencephalograph EEG monitoring is the gold standard for recognizing and treating seizures in this population It is also very helpful at identifying which children have sustained brain injury including hypoxia This resource intense modality has become the standard of care at many tertiary medical centers but unfortunately remains unavailable to many clinicians at smaller birth facilities Quantitative EEG including the use of amplitude integrated EEG aEEG has gained widespread use at most neonatal ICUs and represents a more user friendly bedside tool for identifying brain injury and seizures The proposed phase II project aims to design build and evaluate a low cost telemedicine enabled aEEG monitor and associated multi instrument software package that supports widespread use of aEEG in community based birth care facilities Project Narrative The project will develop technology to aid in the diagnosis intervention and improvement of outcomes for neonates born with neurologic complications Treating electrographic seizures in babies with hypoxic ischemic encephalopathy has been associated with less neurological sequelae and improved long term outcomes