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

POWS for NOWS：使用生理标志物作为评估退缩婴儿的客观工具

• 批准号: 10740629
• 负责人: Brynne Archer Sullivan
• 金额: $ 314.97万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10740629
• 关键词: Acceleration; Address; Admission activity; Affect; Algorithms; Assessment tool; Autonomic Dysfunction; Behavior; Caring; Characteristics; Clinical; Clinical Markers; Clinical Trials; Complex; Data; Data Analytics; Development; Devices; Diagnosis; Disease; Disease Management; Educational workshop; Engineering; Enrollment; Evaluation; Feasibility Studies; Gestational Age; Goals; Gold; Heart Rate; Hospital Costs; Hospitals; Infant; Infant Care; Lead; Length of Stay; Measures; Monitor; Needs Assessment; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Newborn Infant; Observational Study; Parents; Performance; Pharmacological Treatment; Physiological; Physiology; Pregnant Women; Prognosis; Provider; Public Health; Pulse Oximetry; Retrospective cohort; Risk; Sepsis; Severities; Surveys; Symptoms; System; Testing; Time; Translating; United States; Variant; Withdrawal; Withdrawal Symptom; cohort; coronavirus pandemic; design; feasibility testing; heart rate variability; high risk infant; improved; maternal opioid use; mathematical model; meetings; neonatal care; novel; opioid exposure; opioid use disorder; pharmacologic; physiologic model; prospective; prototype; respiratory; sensor; standardized care; technology validation; tool

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.

项目摘要 新生儿阿片类药物戒断综合征（Nows）是一种复杂的疾病，具有可变的表现和严重性。 当前用于评估和治疗的黄金标准使用主观评估和非 - 药理学和药理治疗。观察者间评估可变性和重叠的挑战 正常的新生儿行为会导致严重的歧义和护理变化，导致延迟 治疗和出院。新生儿戒断主要通过自主性过度兴奋性表达 可以通过定量分析非侵入性心率（HR）和氧合（SPO2）来检测。一个 现在的客观评估中存在关键的差距；当前的设备或测试无法提供定量 监测或预测戒断症状。使用客观算法缩小此差距将支付 新生儿托儿所和新生儿ICU都有巨大的股息。 初步结果表明，可以使用连续的脉搏血氧仪数据检测到现在的签名 分析和这些与戒断严重程度的临床标记相关。在脉冲中翻译现在的功能 血氧仪数据中撤回的实时客观测量将为提供者和 直接解决这些脆弱婴儿的主要差距。在这个项目中，我们将使用来自 为了改善和验证脉搏血氧饱和戒断评分（POWS）的术语婴儿现在症状监测 和评估。在现有的商业合作伙伴关系中，我们将开发和测试设备原型 预期可行性研究。为了告知产品设计和工程，我们将从密钥中编译输入 利益相关者，包括父母，提供者和监管机构。完成后，该项目将产生 准备临床试验的设备。