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。 目前的评价和治疗金标准采用主观评价和提供非 药理学和药理学治疗。观察者间评估变异性和重叠的挑战 与正常的新生儿行为导致大量的模糊性和变化的照顾，有助于延迟 治疗和出院。新生儿戒断主要表现为自主神经过度兴奋， 其可以通过无创心率（HR）和氧合（SpO 2）的定量分析来检测。一 NOWS的客观评估存在关键差距;目前没有任何设备或测试可以提供定量的 监测或预测戒断症状。使用客观的算法来缩小这一差距将是值得的 新生儿托儿所和新生儿重症监护室都获得了巨大的红利。 初步结果表明，NOWS的签名可以使用连续脉搏血氧饱和度数据检测 分析，这些与戒断严重程度的临床标志物相关。脉动中NOWS的翻译特点 将血氧测定数据转化为戒断的实时客观测量将为提供者提供可操作的工具， 直接解决这些脆弱婴儿护理方面的主要差距。在这个项目中，我们将使用来自 足月婴儿，以完善和验证用于NOWS症状监测的脉搏血氧仪戒断评分（POWS） 和评估。在现有的商业合作伙伴关系中，我们将开发和测试一个设备原型， 前瞻性可行性研究。为了通知产品设计和工程，我们将汇编来自关键字的输入， 利益相关者，包括家长、供应商和监管机构。项目完成后， 准备好进行临床试验。