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.

抽象的 在2004年之间，新生儿阿片类药物戒断综合征的发病率大于5倍 2014年。尽管这个问题具有重要意义，但在最佳实践方面仍然存在许多关键差距 为了识别和管理现在的婴儿，以及我们对 这些婴儿。小儿医疗保健的变化很常见，并导致患者结局的差异。 该想法状态指出儿科临床试验网络（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）独特地准备 解决与现在相关的现有知识差距。 ISPCTN由> 20个新生儿重症监护 单位和NRN由> 50个新生儿重症监护病房组成。我们正在利用ISPCTN和NRN 要完成两项临床试验，以评估干预措施，以改善受婴儿和家庭影响的护理 现在：1）评估饮食，睡眠，安慰（ESC）护理的临床试验方案 直到受医学影响的婴儿准备出院的时间长度（24个地点）， > 1000个婴儿）； 2）一项临床试验方案，评估是否停止了吗啡的早期断奶方案 现在治疗的婴儿将减少阿片类药物治疗的天数（25个部位，500名婴儿）。目标 该项目的是开发数据标准，以在婴儿阿片类药物中使用的婴儿中用于临床研究 曝光社区。我们将提供常见的数据元素（CD）和报告格式来协助 研究人员使用Finnegan Neonatal量化了现在的婴儿中戒断的严重程度 节制评分工具（FNAST）或ESC试验的ESC。我们将发展一致的严重性 通过使用现有 数据元素并在需要时创建新的数据元素。