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

新生儿阿片类药物戒断综合症 (NOWS) 的诊断和 NOWS-App 的开发

• 批准号: 10709660
• 负责人: Charles Steiner
• 金额: $ 89.72万
• 依托单位: PEDIALYDX INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-22 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10709660
• 关键词: Abdominal colic; Acoustics; Adoption; Algorithms; Birth; Cellular Phone; Child Care; Clinical; Computer software; Cost Savings; Crying; Data; Data Set; Development; Diagnosis; Eating; Exposure to; Family; Feedback; Focus Groups; Freezing; Funding; Health; Health Insurance Portability and Accountability Act; Hospital Charges; Hospitalization; Hospitals; Infant; Location; Machine Learning; Measurement; Medical; Methods; Modification; Multicenter Studies; Neonatal Abstinence Syndrome; Noise; Nurses; Opioid; Pain; Parents; Patients; Pharmacological Treatment; Phase; Public Health; Recording of previous events; Research; Research Personnel; Sampling; Savings; Site; Sleep; Small Business Innovation Research Grant; System; Time; United States National Institutes of Health; Universities; Withdrawal; Woman; Work; accurate diagnosis; algorithm development; algorithm training; autism spectrum disorder; automated analysis; cloud based; commercialization; cost; design; developmental disease; experience; improved; innovation; machine learning algorithm; pharmacologic; prenatal exposure; product development; screening; software development; technology platform

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.

项目概要 PedialyDx Inc. 提议复制之前的研究成果并开发一种商业产品 协助诊断新生儿阿片类药物戒断综合症 (NOWS)，即婴儿的戒断症状 由于胎儿突然停止接触阿片类药物，出生后不久就有过这种经历。 已成为一个重大的公共卫生问题，从 2004 年的每 1000 名新生儿中 1.6 例增加到每 1000 名新生儿中 8.8 例 2016 年，相关医院费用从 2000 年的 1.9 亿美元增加到 2009 年的 7.2 亿美元。准确 NOWS 的诊断很重要，因为假阳性可能会导致婴儿不必要地接受治疗 药物治疗会导致相应的长期住院和巨额费用，或者错误 阴性结果会导致婴儿在应该得到治疗的时候得不到治疗，从而可能导致严重的医疗问题。 不幸的是，目前诊断NOWS 的方法，无论是否基于药理学，例如“金 标准”芬尼根评分系统，或非药理学基础，例如“East、Sleep 和 Console” 由于其主观性而受到限制。 通过算法，我们的团队已经确定了一个初步的“哭声特征”，将婴儿哭声与 Finnegan 相关联 PedialyDx 的 NOWS 应用程序将为 2 岁以下患有 NOWS 的儿童提供更好的护理。 创新点：1）使用声学哭泣分析进行更客观的评估将导致更准确的诊断和 治疗（更少的假阳性、更少的假阴性以及更精确的住院时间）和 2) 保存 我们的初步数据显示，使用NOWS 管理婴儿可以节省时间。 在单一受控临床环境中收集，这证明了我们的算法可以 接下来，我们将通过扩大NOWS应用程序的商业化。 在现有数据集的基础上，通过从现实世界的设置中收集数据来优化我们的 ML 算法。 目标1，我们将进行一项多中心研究（7个地点），以扩展婴儿哭声作为婴儿哭声指标的研究 在目标 2 中，我们将完成 NOWS-app 的开发 成功完成该项目。 将使我们的NOWS-App 产品准备好提交给 FDA 本申请中提出的工作。 还将允许 PedialyDx 采取重要步骤来推进其婴儿哭声技术平台，以实现 用于其他疾病的产品，例如筛查自闭症和其他发育障碍、绞痛和疼痛。