CLINICAL STUDY OF VESICOURETERAL REFLUX IN CHILDREN

儿童膀胱输尿管反流的临床研究

基本信息

批准号：
7457846
负责人：
Myra A. Carpenter
金额：
$ 181.58万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
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/7457846
关键词：
Adherence Administrative Coordination Ancillary Study Antibiotic Prophylaxis Antibiotic Therapy Bar Codes Biochemistry Biometry Child Clinical Clinical Research Clinical Treatment Clinical Trials Data Monitoring Committees Collaborations Collection Commit Communication Contracts Controlled Clinical Trials DMSA Data Data Collection Data Coordinating Center Data Quality Data Reporting Data Set Databases Development Documentation Electronics Epidemiology Informed Consent Internet Intervention Intervention Studies Journals Kidney Label Laboratories Location Manuals Manuscripts Measurement Measures Methods Monitor National Institute of Diabetes and Digestive and Kidney Diseases North Carolina Online Systems Operative Surgical Procedures Participant Peer Review Performance Placebo Control Procedures Process Protocols documentation Publishing Qualifying Randomized Reading Reporting Research Design Research Personnel Retrieval Risk Role Scanning Site Specimen System United States National Institutes of Health Universities Ureter Urinary tract infection Urine Validation Vesico-Ureteral Reflux Vial device abstracting clinical research site data management design experience prevent programs quality assurance renal scarring repository symposium treatment center

项目摘要

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）：该提案的主要目标是在北卡罗来纳大学合作研究协调中心 (CSCC) 内建立儿童膀胱输尿管反流 (VURC) 临床研究数据协调中心 (DCC)。膀胱输尿管反流 (VUR) 的特点是尿液逆流至输尿管。 VUR 会增加尿路感染的风险，大约三分之一患有尿路感染的儿童也患有 VUR。对于 VUR 的最佳治疗方法，或者任何治疗是否有益，人们知之甚少。 VURC 研究的目的是确定特定干预措施是否有益。候选干预措施包括开放手术、内窥镜手术或抗生素预防。我们提出一项随机、安慰剂对照临床试验，预防性抗生素治疗可预防肾脏疤痕形成。关于研究设计和待评估干预措施的最终决定[原文如此]将由指导委员会在项目的前 6 个月内做出。 CSCC 的作用是合作和协调研究方案、程序手册和数据收集表格的制定。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 将设计和开发一个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，并在必要时管理与中心实验室和阅片中心的分包合同。我们将在临床中心、实验室和阅片中心建立并维护关键研究措施的质量保证计划。在整个研究过程中，我们将维护研究网站，为研究研究者和数据和安全监测委员会准备定期数据报告，并协调研究会议。 CSCC 研究人员将为科学会议准备摘要，并准备在同行评审期刊上发表的手稿。简而言之，CSCC 将为拟议的儿童膀胱输尿管反流临床研究提供重要的行政和科学支持