Diagnosis of Neonatal Opioid Withdrawal Syndrome (NOWS) and development of a NOWS-App

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PROJECT SUMMARY PedialyDx Inc. proposes to replicate previous research findings and develop a commercial product that can assist in the diagnosis of Neonatal Opioid Withdrawal Syndrome (NOWS), the withdrawal that infants experience shortly after birth due to the abrupt discontinuation of fetal exposure to opioids. NOWS has become a significant public health problem, increasing from 1.6 per 1000 births in 2004 to 8.8 per 1000 births in 2016, with associated hospital charges increasing from $190M in 2000 to $720M in 2009. Accurate diagnosis of NOWS is important because false-positives can result in babies unnecessarily receiving pharmacological treatment with corresponding prolonged hospitalization and substantial cost, or false- negatives result in babies not being treated when they should, potentially leading to serious medical problems. Unfortunately, current methods to diagnose NOWS, whether pharmacologically based such as the “gold standard” Finnegan scoring system, or non-pharmacologically based such as “East, Sleep and Console” are limited because of their subjectivity. Using proprietary acoustic analysis software and Machine Learning (ML) algorithms, our team has identified a preliminary “cry signature” relating baby cry acoustics to the Finnegan with .81 accuracy. PedialyDx’s NOWS-app will deliver improved care for children with NOWS through 2 innovations: 1) more objective assessment using acoustic cry analysis will lead to more accurate diagnosis and treatment (fewer false positives, fewer false negatives, and more precise hospitalization stays) and 2) save time, leading to cost savings, in the management of babies with NOWS. Our preliminary data has been collected in a single controlled clinical setting, which has demonstrated proof of concept that our algorithm can objectively assess baby cries. Next, we will advance the commercialization of our NOWS-app by expanding upon our existing dataset by collecting data from real-world settings to optimize our ML algorithm for NOWS. In Aim 1, we will conduct a multi-center study (7 sites) to extend the research of baby cry as an indicator of NOWS. In Aim 2, we will complete the development of the NOWS-app. Successful completion of this project will result in our NOWS-App product ready for submission to the FDA. The work proposed in this application will also allow PedialyDx to take important steps toward advancing its baby cry technology platform to enable products for other conditions, such as screening for autism and other developmental disorders, colic and pain.