ACT-NOW Data Sustainability - ECHO Administrative Supplement

摘要 新生儿阿片类药物戒断综合征(NOWS)的发生率从2004年到 2014年。尽管这个问题很重要，但在最佳做法方面仍然存在许多关键差距。 用于识别和处理患有NOWS的婴儿，以及我们对 这些婴儿。儿科医疗护理的差异是常见的，也是导致患者预后差异的原因之一。 这个想法陈述了儿科临床试验网络(ISPCTN)，它是环境影响的一部分 儿童健康结果(ECHO)计划和新生儿研究网络(NRN)正准备独特地 解决与NOW相关的现有知识差距。ISPCTN由20个新生儿重症监护室组成 NRN由50个新生儿重症监护病房组成。我们正在利用ISPCTN和NRN 完成两项临床试验，以评估改善受影响婴儿和家庭护理的干预措施 现在：1)评估饮食、睡眠、安慰(ESC)护理最佳使用的临床试验方案 关于受NOWS影响的婴儿在医疗上准备好出院之前的时间长度的方法(24站点， 1000名婴儿)；以及2)一项临床试验方案，评估早期戒断吗啡方案是否适用于 接受NOWS治疗的婴儿将减少阿片类药物治疗的天数(25个地点，500名婴儿)。目标是 该项目的目的是开发用于宫内阿片类药物婴儿临床研究的数据标准。 暴露社区。我们将提供通用数据元素(CDE)和报告格式以帮助 研究人员使用芬尼根新生儿问卷对NOWS婴儿的戒断程度进行了量化 戒断评分工具(FNAST)或ESC试验中的ESC。我们将制定协调的严重程度 临床研究和患者登记中具有NOWS定义的婴儿使用现有的 数据元素，并在需要时创建新的数据元素。

ABSTRACT The incidence of neonatal opioid withdrawal syndrome (NOWS) increased greater than 5-fold between 2004 to 2014. Despite the significance of this problem, numerous critical gaps remain with respect to the best practices for identification and management of infants with NOWS, along with our understanding of the outcomes of these infants. Variation in pediatric medical care is common and contributes to differences in patient outcomes. The IDeA States Pediatric Clinical Trials Network (ISPCTN), which is part of the Environmental influences on Child Health Outcomes (ECHO) Program, and the Neonatal Research Network (NRN) are uniquely poised to address existing knowledge gaps associated with NOWS. The ISPCTN consists of >20 neonatal intensive care units and the NRN consists of >50 neonatal intensive care units. We are leveraging the ISPCTN and the NRN to complete two clinical trials to evaluate interventions to improve the care of infants and families affected by NOWS: 1) a clinical trial protocol evaluating the optimal use of the Eating, Sleeping, Consoling (ESC) care approach on the length of time until infants affected by NOWS are medically ready for discharge (24 site, >1000 infants); and 2) a clinical trial protocol evaluating whether an early stop weaning protocol for morphine in infants treated for NOWS will decrease the number of days of opioid treatment (25 sites, 500 infants). The goal of this project is to develop data standards for use in clinical research within the infants with in utero opioid exposure community. We will provide common data elements (CDEs) and reporting formats to assist researchers quantify the severity of withdrawal among infants with NOWS using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or the ESC from the ESC Trial. We will develop harmonized severity of withdrawal among infants with NOWS definitions for clinical research and patient registries by using existing data elements and creating new data elements, when needed.