The goal of this project is to develop a portable, low-cost tool to aid in the diagnosis, intervention and improvement of outcomes for neonates born with neurologic complications. The project will develop instrumentation technology 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 goal of the phase I project is to specify, design, prototype, and evaluate a low-cost, telemedicine-enabled aEEG monitor that is portable and supports widespread use in smaller facilities. A prototype instrument will be specified, designed, built, and evaluated. The follow-on phase II program will conduct a large human trial.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD085742-01
Application #
8988800
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Higgins, Rosemary
Project Start
2015-07-01
Project End
2016-06-30
Budget Start
2015-07-01
Budget End
2016-06-30
Support Year
1
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Advanced Medical Electronics Corporation
Department
Type
DUNS #
927303412
City
Maple Grove
State
MN
Country
United States
Zip Code
55369