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: 10602627
• 负责人: Charles Steiner
• 金额: $ 93.7万
• 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/10602627
• 关键词: Abdominal colic; Acoustics; Adoption; Algorithms; Birth; Cellular Phone; Child Care; Clinical; Computer software; Cost Savings; Data; Data Set; Development; Diagnosis; Eating; Exposure to; Family; Feedback; Focus Groups; Freezing; Funding; Gold; 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; Pharmacology; Phase; Public Health; Recording of previous events; Research; Research Personnel; Sampling; Savings; Site; Sleep; Small Business Innovation Research Grant; System; Technology; Time; Treatment Cost; United States National Institutes of Health; Universities; Withdrawal; Woman; Work; accurate diagnosis; algorithm development; algorithm training; autism spectrum disorder; automated analysis; base; cloud based; commercialization; cost; design; developmental disease; experience; improved; innovation; machine learning algorithm; prenatal exposure; product development; screening; software development

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.

项目摘要 PETIALYDX Inc.提案，以复制先前的研究结果并开发可以 协助诊断新生儿阿片类药物戒断综合征（NOWS），这是婴儿的戒断 出生后不久，由于胎儿暴露于阿片类药物的突然中断而经历。现在有 成为一个重大的公共卫生问题，从2004年的每1000个分娩增加到每1000个出生的8.8 2016年，相关医院收费从2000年的1.9亿美元增加到2009年的7.2亿美元。准确 诊断现在很重要，因为假阳性可能会导致婴儿不必要的接收 药理学治疗，相应的住院时间相应和大量成本或假 负面因素会导致婴儿在应有的何时受到治疗，可能导致严重的医疗问题。 不幸的是，当前诊断的方法是基于“金黄金”的药物 标准” Finnegan评分系统，或基于“ East，Sleep and Console”等非药理学 由于其主观性而有限。使用专有声学分析软件和机器学习（ML） 算法，我们的团队已经确定了一个初步的“哭泣签名”，与Finnegan相关的婴儿哭泣声音 具有.81精度。 Pedialydx的Nows-App将为Nows提供2到2的儿童提供改进的护理 创新：1）使用声学哭泣分析进行更多客观评估将导致更准确的诊断和 治疗（较少的假阳性，较少的假否定性和更精确的住院住院）和2）保存 时间，导致节省成本，管理现在的婴儿。我们的初步数据已经 在单个受控的临床环境中收集，这证明了我们的算法可以 客观地评估婴儿哭泣。接下来，我们将通过扩展来推进我们的nows-app的商业化 在我们现有的数据集上，通过从现实世界设置收集数据，以优化现在的ML算法。在 AIM 1，我们将进行一项多中心研究（7个地点），以扩展婴儿哭泣的研究作为指标 现在。在AIM 2中，我们将完成Nows-App的开发。成功完成该项目 将导致我们的Nows-App产品准备提交给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泣技术平台以启用 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。