CLINICAL STUDY OF VESICOURETERAL REFLUX IN CHILDREN

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): [unreadable] 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. [unreadable] 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 [unreadable] [unreadable]