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 NeoGUARDâs output to the clinical decisions made by human experts.
Public Health Relevance Statement: PROJECT NARRATIVE Neonatal Opioid Withdrawal Syndrome (NOWS) affects over 20,000 newborn babies every year, resulting in over $2 billion in addition cost for our health care system. Subjective, complex and time-consuming clinical observation is the primary modality used today to screen for and determine the severity of the condition. This project aims at improving the care of NOWS neonates and lowering associated costs by providing the NeoGUARDTM to care providers, an easy-to-use, non-invasive and low-cost brain monitor to objectively screen for the condition, guide and monitor therapeutic intervention.
Project Terms: Affect; Aftercare; Algorithms; Asphyxia Neonatorum; Assessment tool; base; Beds; behavior observation; Body Weight decreased; Brain; brain abnormalities; brain health; care providers; Caring; case control; Cause of Death; Cerebrum; Cessation of life; Clinical; clinical database; Communities; Complex; Computer software; Consumption; cost; Custom; Databases; Detection; Development; Device Designs; Devices; Diagnosis; Diagnostic; disability; Electroencephalography; Encephalopathies; Ensure; Evaluation; evidence base; Excision; Exposure to; Failure to Thrive; Family; Fees; Goals; Health Care Costs; Healthcare Systems; Hour; Human; improved; in utero; Infant; innovation; insight; Intervention; Lead; Left; Length of Stay; Literature; Medical; Medical center; Medical Device; medical schools; Medicine; Modality; Monitor; Morphologic artifacts; Mothers; Nature; Neonatal; Neonatal Abstinence Syndrome; neonatal care; neonatal encephalopathy; Neonatal Intensive Care Units; Neonatal Screening; neonate; neurobehavioral; Neurologic; neuropathology; Newborn Infant; Opioid; opioid epidemic; opioid exposure; opioid use in pregnancy; opioid withdrawal; Outcome; Output; Pathology; Patients; Pattern; Pharmacological Treatment; Pharmacology; Phase; Premature Infant; Price; programs; Protocols documentation; prototype; Provider; Publishing; real time monitoring; Risk; Rural; Sales; screening; Seizures; Severities; Signal Transduction; Sleep disturbances; Sleep Wake Cycle; Standardization; Subclinical Seizures; Substance Withdrawal Syndrome; success; Suggestion; Symptoms; Syndrome; System; technological innovation; Testing; Therapeutic Intervention; Time; tool; Training; United States; Universities; Visual; Washington; Withdrawal; Withdrawal Sympto
