NeoGUARD: An easy-to-use, low-cost brain monitor for objective screening and treatment of opioid-exposed infants - PROJECT SUMMARY / ABSTRACT
The goal of this project is to develop an innovative, low-cost, non-invasive and easy-to-use brain monitor to
objectively assess the severity of withdrawal symptoms in newborns exposed to opioids and provide evidence-
based decision support to care providers to improve both short- and long-term developmental outcomes.
Neonatal Opioid Withdrawal Syndrome (NOWS) affects a growing number of neonates each year due to the
ongoing opioid epidemic ravaging the United States. It is estimated that 1 baby born every 25 minutes is
suffering from the condition, which results in over $60,000 in additional costs.
As of today, there is no quantitative diagnostic tool available to make the NOWS determination. Complex
neurobehavioral observation of newborns is the primary modality used. It is subjective and time-consuming by
nature, requires significant expertise, and can lead to delays in treatment. Furthermore, inter-rater reliability
issues may confound therapeutic intervention. As a result, care providers in community or rural medical
centers frequently refer their newborn patients with suspected NOWS to tertiary Neonatal Intensive Care Units
(NICUs) with more advanced neonatal care, but at significant cost to the family and healthcare system.
The aim of this Phase I is to develop a medical device for quantitative assessment of neonates, in order to
screen for NOWS and quantify the severity of the condition. This device, referred to as NeoGUARD, is based
on the continuous, automated and real-time monitoring of brain function to detect EEG abnormalities shown to
be related to NOWS and determine severity to guide pharmacological intervention. This device will enable
providers, including those at lower level centers, to effectively manage infants with NOWS.
The envisioned device will build upon our commercial line of low-cost, limited-channel EEG monitors, to be
customized for use in neonates. Our systems feature built-in algorithms for reliable detection/removal of EEG
artifacts in real time, critical for any automated EEG analysis. NeoGUARD will further embed amplitude-
integrated EEG (aEEG) algorithms/features validated by our collaborators at Washington University School of
Medicine (WUSM), as well as our proprietary quantitative EEG (qEEG) algorithms indicative of EEG
abnormalities and their severity. The aEEG and qEEG features will then be combined into an overall Brain
Health Score (BHS) to give providers a simple, objective endpoint to guide goal-directed therapy.
To ensure this project success, we will partner with the Division of Newborn Medicine at WUSM. Their
expertise in NOWS, neonatal encephalopathy, quantitative analysis of limited-channel EEG, and their
extensive database of neonatal EEG recordings will support the development and testing of the NeoGUARD.
The Phase I will focus on the prototyping of the hardware and software platform and its initial evaluation
using WUSM database. Feasibility will be demonstrated by comparing the NeoGUARD’s output to the clinical
decisions made by human experts.
