CLINICAL STUDY OF VESICOURETERAL REFLUX IN CHILDREN

儿童膀胱输尿管反流的临床研究

• 批准号: 7036448
• 负责人: Myra A. Carpenter
• 金额: $ 91.07万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7036448
• 关键词: antiinfective agents; biomedical facility; chemoprevention; clinical research; clinical trials; cooperative study; data collection methodology /evaluation; data management; disease /disorder prevention /control; epidemiology; human therapy evaluation; infant human (0-1 year); injury; kidney disorder; method development; pediatric pharmacology; pediatrics; preschool child (1-5); relapse /recurrence; scars; statistics /biometry; urinary bladder disorder; urinary tract imaging /visualization; urinary tract infection

DESCRIPTION (provided by applicant): The primary objective of this proposal is to establish a Data Coordinating Center (DCC) for the Clinical Study of Vesicoureteral Reflux in Children (VURC) within the Collaborative Studies Coordinating Center (CSCC) at the University of North Carolina. Vesicoureteral reflux (VUR) is characterized by the retrograde flow of urine up the ureter. VUR increases the risk of urinary tract infection, and approximately one-third of the children who have urinary tract infections also have VUR. Little is known about the best treatment for VUR, or whether any treatment is beneficial. The objective of the VURC study is to determine whether a specific intervention is beneficial. Candidate interventions are open surgery, endoscopic surgery, or antibiotic prophylaxis. We propose a randomized, placebo-controlled clinical trial of prophlaxic [sic] antibiotic therapy to prevent renal scarring. The final descision [sic] on the design of the study and the intervention(s) to be evaluated will be made by the Steering Committee during the first 6 months of the project. The role of the CSCC will be to collaborate on and coordinate the development of the study protocol, manuals of procedures, and data collection forms. We will provide expertise in epidemiology, biostatistics, and data management. The CSCC will design and develop a web-based data management system for use in the multi-center study. We will coordinate with the NIDDK specimen and data repositories, and if necessary, manage subcontracts with central laboratories and reading centers. We will establish and maintain a quality assurance program within the clinical sites, laboratories, and reading centers for key study measures. Throughout the study, we will maintain the study web site, prepare regular data reports for study investigators and the Data and Safety Monitoring Board, and coordinate study meetings. CSCC investigators will prepare abstracts for scientific meetings and manuscripts to be published in peer-reviewed journals. In short, the CSCC will provide important administrative and scientific support to the proposed Clinical Study of Vesicoureteral Reflux in Children

描述（由申请人提供）： 该提案的主要目的是建立一个数据协调中心（DCC），用于在北卡罗来纳大学协调研究中心（CSCC）的儿童囊泡级回流（VURC）的临床研究。囊泡排回流（VUR）的特征是输尿管上的尿液逆行流动。 VUR增加了尿路感染的风险，大约三分之一的患有尿路感染的儿童也患有VUR。关于VUR的最佳治疗方法，或任何治疗方法是否有益。 VURC研究的目的是确定特定的干预措施是否有益。候选干预措施是开放手术，内窥镜手术或抗生素预防。我们提出了一项随机的，安慰剂对照的抗生素治疗的临床试验，以防止肾脏疤痕。在项目的前6个月中，指导委员会将进行研究的最终下降[SIC]和要评估的干预措施。 CSCC的作用将是协作并协调研究协议的开发，手册和数据收集表。我们将提供流行病学，生物统计学和数据管理方面的专业知识。 CSCC将设计并开发基于网络的数据管理系统，用于多中心研究。我们将与NIDDK标本和数据存储库进行协调，并在必要时与中央实验室和阅读中心管理分包合同。我们将在临床站点，实验室和阅读中心内建立并维护质量保证计划，以进行关键研究措施。在整个研究中，我们将维护研究网站，为研究调查人员和数据和安全监测委员会准备定期的数据报告，并协调研究会议。 CSCC调查人员将准备摘要，以在同行评审期刊上发表的科学会议和手稿。简而言之，CSCC将为拟议的儿童囊泡反流的临床研究提供重要的行政和科学支持