Research Support Core - Outcomes of Babies with Opioid Exposure (OBOE)

项目摘要/摘要 阿片依赖在美国的流行以及随之而来的阿片依赖数量的增加 出生时患有新生儿阿片类药物戒断综合征(NOWS)的婴儿有可能严重影响NOWS 不仅是当代人，也是未来的一代。婴儿阿片类药物暴露的结局(双簧管)研究 将审查产前阿片类药物暴露的多维影响和潜在的干预变量， 包括家庭和环境因素。独立的数据协调中心(DCC)井 具有新生儿随访研究和核磁共振数据分析的经验是多中心双簧管的关键 确保采用最佳做法和质量控制的研究，以通过密集的方式最大限度地保留队列 跟踪和协调数据质量监测和分析过程。建立在RTI International的基础上 成功领导了40多个DCC，并与四个拟议的双簧管进行了持续合作 作为新生儿研究网络(NRN)研究支持的一部分，多年来研究临床站点 CORE(RSC)将通过实现以下具体目标最大限度地提高该联盟的生产率：(1) 通过提供科学和组织上的支持来促进该联盟的科学和临床影响 领导研究设计和实施；(2)加快研究启动，确保高质量和 通过对协议执行的有效培训，有效执行研究数据的一致性 跟踪工具和执行严格的电子数据采集系统；(3)促进队列登记和 通过实时监测和报告保留；以及(4)通过以下方式加快研究结果的传播 提供及时的数据分析和数据共享，并实施数据可视化技术以 通过演示文稿和出版物有效地交流成果。Carla Bann博士，拟议的DCC PD/PI和RSC负责人，在为新生儿研究提供统计领导方面有丰富的经验， 包括一项关于产前接触可卡因和/或阿片类药物对较长时间- 期限结果。她将由NRN DCC的候补国际和高级顾问Abhik Das博士协助， 和行政核心负责人，NRN后续协调员杰米·纽曼博士。应用程序具有唯一性 帮助推进财团研究议程的优势：(1)经验丰富、积极进取的PI和 对新生儿随访和产前评估研究有多年经验和深入了解的工作人员 药物暴露和儿童发展；(2)新生儿研究的科学生产力的跟踪记录；(3)a 灵活且可定制的工具、流程和患者跟踪系统的最先进基础设施 以满足新生儿研究的需要；(4)强大的数据采集和管理系统，以确保数据质量； 和(5)具有人员配置灵活性的管理结构，以优化人员部署和快速反应 不断变化的学习需求。

PROJECT SUMMARY/ABSTRACT The epidemic of opioid dependency in the United States and the subsequent increase in the number of infants born with neonatal opioid withdrawal syndrome (NOWS) has the potential to substantially affect not only current generations but also future ones. The Outcomes of Babies with Opioid Exposure (OBOE) Study will examine the multidimensional impact of antenatal opioid exposure and potential intervening variables, including family and environmental factors. An independent Data Coordinating Center (DCC) well experienced in neonatal follow-up studies and analyses of MRI data is essential for the multicenter OBOE Study to ensure adoption of best practices and quality control for maximal cohort retention through intensive tracking and harmonized data quality monitoring and analyses processes. Building on RTI International's successful leadership of more than 40 DCCs and ongoing collaborations with the four proposed OBOE Study Clinical Sites for many years as part of the Neonatal Research Network (NRN), the Research Support Core (RSC) will maximize the productivity of this Consortium by realizing the following specific aims: (1) advance the scientific and clinical impact of the Consortium by providing scientific and organizational leadership for the study design and implementation; (2) expedite study launch and ensure high quality and consistency of study data through effective training on protocol implementation, implementation of effective tracking tools, and execution of rigorous electronic data capture systems; (3) facilitate cohort enrollment and retention through real-time monitoring and reporting; and (4) accelerate dissemination of study findings by providing timely data analyses and data sharing and implementing data visualization techniques to effectively communicate results through presentations and publications. Dr. Carla Bann, the proposed DCC PD/PI and RSC leader, has extensive experience in providing statistical leadership for neonatal studies, including a multisite longitudinal study of the impact of antenatal cocaine and/or opioid exposure on longer- term outcomes. She will be assisted by Alternate PI and Senior Advisor, Dr. Abhik Das, PI for the NRN DCC, and Administrative Core leader, Dr. Jamie Newman, NRN Follow-Up Coordinator. application has unique strengths to help advance the Consortium research agenda: (1) a highly experienced and motivated PI and staff with years of experience and in-depth knowledge of neonatal follow-up and studies assessing antenatal drug exposure and child development; (2) a track record of scientific productivity in neonatal research; (3) a state-of-the-art infrastructure of tools, processes, and patient tracking systems that is flexible and customized to the needs of neonatal studies; (4) robust data capture and management systems to ensure data quality, and (5) an administrative structure with staffing flexibility to optimally deploy personnel and respond quickly to changing study needs.