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

研究支持核心 - 接触阿片类药物的婴儿 (OBOE) 的结果

• 批准号: 9901876
• 负责人: CARLA M BANN
• 金额: $ 271.96万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901876
• 关键词: 2 year old; Adoption; Affect; Back; Certification; Child; Child Development; Clinical; Collaborations; Common Data Element; Communication; Comprehension; Computer Systems; Consensus; Consent; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Data Set; Development; Drug Exposure; Enrollment; Ensure; Environmental Risk Factor; Family; Follow-Up Studies; Fostering; Funding; Future; Future Generations; Generations; Goals; Human Resources; Infant; Infrastructure; Institutional Review Boards; International; Internet; Knowledge; Leadership; Letters; Longitudinal Studies; Magnetic Resonance Imaging; Manuscripts; Medical center; Methods; Monitor; Multicenter Neonatal Research Network; Neonatal; Neonatal Abstinence Syndrome; Opiate Addiction; Outcome; Parents; Participant; Patient Monitoring; Patients; Persons; Procedures; Process; Productivity; Protocols documentation; Psychology; Psychometrics; Publications; Quality Control; Reporting; Research; Research Design; Research Personnel; Research Support; Safety; Science; Scientific Advances and Accomplishments; Site; Statistical Data Interpretation; Structure; System; Techniques; Time; Training; United States; United States National Institutes of Health; Work; addiction; antenatal; base; birth control; clinical research site; cocaine exposure; cohort; dashboard; data sharing; data visualization; design; electronic data capture system; experience; flexibility; follow-up; improved; infant outcome; member; neuroimaging; opioid epidemic; opioid exposure; protocol development; quality assurance; real time monitoring; recruit; safety study; scientific organization; statistics; tool

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.

项目总结/摘要 阿片类药物依赖在美国的流行以及随后的阿片类药物依赖人数的增加， 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 不仅是当代人，也包括未来的人。阿片类药物暴露婴儿（OBOE）研究 将研究产前阿片类药物暴露的多方面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） 在新生儿随访研究和MRI数据分析中的经验对于多中心OBOE至关重要 研究确保采用最佳做法和质量控制，通过强化培训， 跟踪和统一数据质量监测和分析进程。基于RTI国际的 成功领导40多个DCC，并与四个拟议的OBOE持续合作 多年来，作为新生儿研究网络（NRN）的一部分，研究支持 核心（RSC）将通过实现以下具体目标来最大限度地提高该联盟的生产力：（1） 通过提供科学和组织的信息， 领导研究设计和实施;（2）加快研究启动并确保高质量和 通过对方案实施进行有效培训， 跟踪工具，并执行严格的电子数据采集系统;（3）促进队列招募， 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， 通过演讲和出版物有效地传播成果。卡拉班恩博士，拟议中的DCC PD/PI和RSC负责人，在为新生儿研究提供统计领导方面拥有丰富的经验， 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的 长期成果。她将由NRN DCC的副PI和高级顾问Abhik Das博士协助， 和行政核心领导人，杰米纽曼博士，NRN后续协调员。应用程序具有独特的 有助于推进联盟研究议程的优势：（1）经验丰富、积极主动的PI， 具有多年经验和对新生儿随访和产前评估研究有深入了解的工作人员 药物暴露和儿童发育;（2）新生儿研究中科学生产力的跟踪记录;（3） 最先进的工具、流程和患者跟踪系统基础设施，灵活且可定制 新生儿研究的需求;（4）强大的数据采集和管理系统，以确保数据质量， 以及（5）具有灵活性的行政结构，以最佳方式部署人员并迅速作出反应 改变学习需求。