Administrative Core - Outcomes of Babies with Opioid Exposure (OBOE)

行政核心 - 接触阿片类药物的婴儿的结果 (OBOE)

• 批准号: 9901875
• 负责人: Jamie Elizabeth Newman
• 金额: $ 498.24万
• 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/9901875
• 关键词: 2 year old; Address; Area; Birth; Calendar; Caring; Clinical Management; Clinical Trials; Collaborations; Communication; Communication Tools; Complex; Coordination and Collaboration; Custom; Data; Data Collection; Data Coordinating Center; Development; Eating; Ensure; Event; Exposure to; Follow-Up Studies; Fostering; Funding; Goals; Human Resources; Infant; Information Systems; Infrastructure; International; Lead; Leadership; Logistics; Longitudinal Studies; Manuals; Methodology; Monitor; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Abstinence Syndrome; Newborn Infant; Opioid; Outcome; Persons; Policies; Preparation; Privatization; Procedures; Process; Productivity; Protocols documentation; Publications; Recording of previous events; Reporting; Research; Research Personnel; Research Support; Resources; Safety; Schedule; Secure; Services; Sleep; Structure; System; Training; United States National Institutes of Health; Update; Vision; Work; addiction; antenatal; base; clinical practice; clinical research site; cohort; collaborative environment; dashboard; electronic data capture system; experience; flexibility; high risk infant; in utero; infant outcome; innovation; meetings; member; neuroimaging; operation; opioid exposure; organizational structure; participant retention; payment; prenatal exposure; recruit; research study; success; symposium; tool; web site; web-based tool; webinar; working group

PROJECT SUMMARY/ABSTRACT To meet the challenge of collecting high-quality, comprehensive data examining the developmental profile, trajectory, and outcomes of infants with neonatal opioid withdrawal syndrome (NOWS), the HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium requires an experienced Administrative Core that will lead and coordinate the Clinical Sites, Steering Committee, Scientific and Safety Monitoring Committee, and other Consortium members to conduct the Outcomes of Babies with Opioid Exposure (OBOE) Study. The complexity of studying a cohort of newborns exposed to opioids requires rigorous and innovative communicative, organizational, and logistical methodologies to facilitate comprehensive and valid data collection and participant retention. A knowledgeable Administrative Core will allow for the nuanced systemic needs of a study of this magnitude to be efficiently addressed and met. Building on a long, well-established history of leadership in complex DCC efforts, the Administrative Core at RTI International will maximize the productivity of the Consortium and effectively coordinate the interaction among its components by achieving the following specific aims: (1) enhance multisite study coordination and collaboration by providing the Consortium with the necessary logistical, communications, and operational support and (2) manage Clinical Site capitation by implementing an efficient and accurate payment system. Dr. Jamie Newman, the proposed Administrative Core PD/PI, has extensive DCC experience and expertise in follow-up studies of high-risk infants. Dr. Newman's history of collaboration with the proposed PD/PI Dr. Carla Bann and Alternate PD/PI Dr. Abhik Das and with the proposed Clinical Site PD/PIs and research staff will benefit the Consortium and help it more efficiently achieve its goal to develop appropriate care practices and treatments for infants exposed prenatally to opioids. Informed by our ongoing and past DCC accomplishments, we will facilitate the success of the Consortium by establishing an Administrative Core and associated organizational framework that provide a collaborative environment to advance the Consortium research agenda and build on these unique strengths: (1) a state-of-the-art infrastructure of flexible tools, processes, and systems developed by RTI that are currently being used by the proposed Clinical Sites for other multisite studies and that will be further customized to meet the unique needs of the Consortium; (2) an administrative structure that provides staffing flexibility to optimally deploy personnel resources and respond quickly to changing Consortium needs; and (3) a proven track record of collaboration and substantial scientific productivity with the proposed Clinical Site PD/PIs, all members along with the proposed RTI staff of the NICHD Neonatal Research Network, that has frequently changed clinical practice.

项目摘要/摘要 为了满足收集高质量的挑战，综合数据检查了发展 新生儿阿片类药物戒断综合征（NOWS）的婴儿的概况，轨迹和结果 主动性：产前阿片类药物暴露纵向研究联盟需要经验丰富的 行政核心将领导和协调临床站点，指导委员会，科学和安全 监测委员会和其他财团成员用阿片类药物进行婴儿的结果 暴露（双簧管）研究。研究暴露于阿片类药物的新生儿的复杂性需要 严格而创新的交流，组织和后勤方法，以促进 全面有效的数据收集和参与者保留。知识渊博的行政核心将 允许对此类研究的细微差别进行有效解决和满足。 建立在复杂的DCC努力中的漫长，悠久的领导历史的基础上，这是 RTI International将最大化财团的生产率并有效地协调相互作用 通过实现以下特定目的，在其组成部分中：（1）增强多站点研究协调和 通过为财团提供必要的后勤，沟通和运营的协作 支持和（2）通过实施高效且准确的支付系统来管理临床现场人士。 拟议的行政核心PD/PI杰米·纽曼（Jamie Newman）博士拥有丰富的DCC经验和专业知识 在高危婴儿的后续研究中。纽曼博士与拟议的PD/PI博士合作的历史 Carla Bann和替代PD/PI Abhik Das博士以及拟议的临床站点PD/PIS和研究人员 将使财团受益，并帮助其更有效地实现其发展适当的护理实践的目标 和针对阿片类药物的婴儿的治疗。由我们正在进行和过去的DCC告知 成就，我们将通过建立行政核心和 相关的组织框架，提供了一个协作环境来推进财团 研究议程并以这些独特的优势为基础：（1）灵活工具的最先进基础设施， RTI开发的过程和系统目前已被提议的临床站点用于 其他多站点研究将进一步定制以满足财团的独特需求； （2） 行政结构可提供人员配备以最佳部署人员资源的灵活性并做出回应 迅速满足财团需求； （3）合作和实质性的可靠记录 拟议的临床站点PD/PIS的科学生产力，所有成员以及拟议的RTI员工 NICHD新生儿研究网络经常改变临床实践。