ACT-NOW Data Sustainability - ECHO Administrative Supplement

立即行动数据可持续性 - ECHO 行政补充

• 批准号: 10628516
• 负责人: Laura Kristin NEWBY
• 金额: $ 9.99万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10628516
• 关键词: Abstinence; Address; Administrative Supplement; Affect; Caring; Child Health; Childhood; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical trial protocol document; Common Data Element; Communities; Data; Data Element; Data Reporting; Diagnosis; Eating; Family; Goals; Incidence; Infant; Infant Care; Intervention; Knowledge; Length; Medical; Morphine; Multicenter Neonatal Research Network; Neonatal; Neonatal Abstinence Syndrome; Neonatal Intensive Care Units; Opioid; Outcome; Patient-Focused Outcomes; Protocols documentation; Public Health; Research Design; Research Personnel; Rural Population; Severities; Site; Sleep; Time; Treatment outcome; Variant; Weaning; Withdrawal; data standards; improved; in utero; infant outcome; opioid exposure; opioid use disorder; patient registry; programs; standard of care; tool

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.

摘要 新生儿阿片类药物戒断综合征（NOWS）的发病率在2004年至2010年期间增加了5倍以上。 2014.尽管这一问题很重要，但在最佳做法方面仍存在许多重大差距 对于NOWS婴儿的识别和管理，沿着我们对 这些婴儿。儿科医疗护理的变化是常见的，并导致患者结局的差异。 IDEA国家儿科临床试验网络（ISPCTN），这是环境影响的一部分， 儿童健康成果（ECHO）计划和新生儿研究网络（NRN）是唯一准备， 解决与NOWS相关的现有知识差距。ISPCTN包括>20个新生儿重症监护 新生儿护理网由50多个新生儿重症监护室组成。我们正在利用ISPCTN和NRN 完成两项临床试验，评估干预措施，以改善对受影响的婴儿和家庭的护理， NOWS：1）一项临床试验方案，评估进食、睡眠、安慰（ESC）护理的最佳使用 关于受NOWS影响的婴儿在医学上准备出院的时间长短的方法（24个地点， >1000名婴儿）;和2）临床试验方案，其评估在哺乳动物中早期停止吗啡断奶方案是否 接受NOWS治疗的婴儿将减少阿片类药物治疗的天数（25个研究中心，500名婴儿）。目标 该项目的目的是制定用于宫内阿片类药物婴儿临床研究的数据标准 曝光社区我们将提供通用数据元素（CDE）和报告格式， 研究人员使用Finnegan新生儿量表量化了NOWS婴儿戒断的严重程度。 禁欲评分工具（FNAST）或ESC试验中的ESC。我们将制定统一的严重程度， 通过使用现有的临床研究和患者登记， 数据元素并在需要时创建新的数据元素。