POWS for NOWS: Using physiomarkers as an objective tool for assessing the withdrawing infant

项目总结 新生儿阿片戒断综合征(NOWS)是一种复杂的疾病，具有不同的表现和严重程度。 目前的评估和治疗的黄金标准使用主观评估和提供非 药理和药理治疗。观察员间评估的可变性和重叠方面的挑战 正常的新生儿行为导致护理上的大量模棱两可和差异，导致延误 治疗和出院。新生儿的戒断主要是通过自主神经过度兴奋来表达的， 可通过无创心率(HR)和血氧饱和度(SpO2)的定量分析来检测。一个 NOWS的客观评估存在严重差距；目前的任何设备或测试都无法提供定量的 监测或预测戒断症状。使用客观算法缩小这一差距将是有回报的 新生儿保育室和新生儿重症监护室都有巨大的红利。 初步结果表明，使用连续脉搏血氧仪数据可以检测到NOWS的特征 分析和这些与戒断严重程度的临床标志相关。PULSE中NOWS的翻译特点 将血氧监测数据转化为实时客观的戒断措施将为提供者和 直接解决这些脆弱婴儿护理方面的主要差距。在本项目中，我们将使用来自 足月儿用于NOWS症状监测的脉搏血氧饱和度戒断评分(POWS)的改进和验证 和评估。在现有的商业合作伙伴关系中，我们将在一个 前瞻性可行性研究。为了给产品设计和工程提供信息，我们将汇编来自KEY的输入 利益相关者，包括家长、提供者和监管机构。建成后，该项目将产生 该设备已准备好进行临床试验。

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.