SBIR/STTR Award attributes
PROJECT SUMMARYABSTRACTThe goal of this project is to develop an innovativelow costnon invasive and easy to use brain monitor to objectively assess the severity of withdrawal symptoms in newborns exposed to opioids and provide evidencebased decision support to care providers to improve both shortand long term developmental outcomesNeonatal Opioid Withdrawal SyndromeNOWSaffects a growing number of neonates each year due to the ongoing opioid epidemic ravaging the United StatesIt is estimated thatbaby born everyminutes is suffering from the conditionwhich results in over $in additional costsAs of todaythere is no quantitative diagnostic tool available to make the NOWS determinationComplex neurobehavioral observation of newborns is the primary modality usedIt is subjective and time consuming by naturerequires significant expertiseand can lead to delays in treatmentFurthermoreinter rater reliability issues may confound therapeutic interventionAs a resultcare providers in community or rural medical centers frequently refer their newborn patients with suspected NOWS to tertiary Neonatal Intensive Care UnitsNICUswith more advanced neonatal carebut at significant cost to the family and healthcare systemThe aim of this Phase I is to develop a medical device for quantitative assessment of neonatesin order to screen for NOWS and quantify the severity of the conditionThis devicereferred to as NeoGUARDis based on the continuousautomated and real time monitoring of brain function to detect EEG abnormalities shown to be related to NOWS and determine severity to guide pharmacological interventionThis device will enable providersincluding those at lower level centersto effectively manage infants with NOWSThe envisioned device will build upon our commercial line of low costlimited channel EEG monitorsto be customized for use in neonatesOur systems feature built in algorithms for reliable detection removal of EEG artifacts in real timecritical for any automated EEG analysisNeoGUARD will further embed amplitudeintegrated EEGaEEGalgorithms features validated by our collaborators at Washington University School of MedicineWUSMas well as our proprietary quantitative EEGqEEGalgorithms indicative of EEG abnormalities and their severityThe aEEG and qEEG features will then be combined into an overall Brain Health ScoreBHSto give providers a simpleobjective endpoint to guide goal directed therapyTo ensure this project successwe will partner with the Division of Newborn Medicine at WUSMTheir expertise in NOWSneonatal encephalopathyquantitative analysis of limited channel EEGand their extensive database of neonatal EEG recordings will support the development and testing of the NeoGUARDThe Phase I will focus on the prototyping of the hardware and software platform and its initial evaluation using WUSM databaseFeasibility will be demonstrated by comparing the NeoGUARD s output to the clinical decisions made by human experts PROJECT NARRATIVENeonatal Opioid Withdrawal SyndromeNOWSaffects overnewborn babies every yearresulting in over $billion in addition cost for our health care systemSubjectivecomplex and time consuming clinical observation is the primary modality used today to screen for and determine the severity of the conditionThis project aims at improving the care of NOWS neonates and lowering associated costs by providing the NeoGUARDTM to care providersan easy to usenon invasive and low cost brain monitor to objectively screen for the conditionguide and monitor therapeutic intervention
