PROJECT SUMMARY Neonatal Opioid Withdrawal Syndrome (NOWS) is a complex disorder with variable presentation and severity. The current gold standard for evaluation and treatment uses subjective evaluation and provision of non- pharmacologic and pharmacologic treatments. Challenges in inter-observer assessment variability and overlap with normal neonatal behavior leads to substantial ambiguity and variation in care, contributing to delays in treatment and discharge. Neonatal withdrawal is expressed predominantly through autonomic hyperexcitability, which can be detected through quantitative analysis of non-invasive heart rate (HR) and oxygenation (SpO2). A critical gap exists in the objective assessment of NOWS; no current device or test can provide a quantitative monitoring or prediction of withdrawal symptoms. Closing this gap using an objective algorithm would pay enormous dividends in both the Newborn Nursery and the Neonatal ICU. Preliminary results indicate that signatures of NOWS can be detected using continuous pulse oximetry data analytics and these correlate with clinical markers of withdrawal severity. Translating features of NOWS in pulse oximetry data into a real-time objective measure of withdrawal would provide an actionable tool for providers and directly address the primary gap in the care of these vulnerable infants. In this project, we will use data from term infants to refine and validate a Pulse Oximetry Withdrawal Score (POWS) for NOWS symptom monitoring and assessment. In an existing commercial partnership, we will develop and test a device prototype in a prospective feasibility study. To inform product design and engineering, we will compile input from key stakeholders, including parents, providers, and regulatory bodies. Upon completion, the project will yield a device ready for a clinical trial.

PROJECT NARRATIVE Neonatal Opioid Withdrawal syndrome (NOWS) affects an increasing number of infants as the US rate of maternal Opioid Use Disorder continues to rise. Current standard NOWS management uses subjective scoring systems that result in significant variability in diagnosis and treatment. We aim to optimize and validate technology for objective NOWS assessment based on physiology using a single ubiquitous device, pulse oximetry, with the goal to improve care of infants with NOWS.