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
| Mattoo, Tej K; Skoog, Steven J; Gravens-Mueller, Lisa et al. (2017) Interobserver variability for interpretation of DMSA scans in the RIVUR trial. J Pediatr Urol 13:616.e1-616.e6 |
| Schaeffer, Anthony J; Greenfield, Saul P; Ivanova, Anastasia et al. (2017) Reliability of grading of vesicoureteral reflux and other findings on voiding cystourethrography. J Pediatr Urol 13:192-198 |
| Primack, William; Bukowski, Timothy; Sutherland, Richard et al. (2017) What Urinary Colony Count Indicates a Urinary Tract Infection in Children? J Pediatr 191:259-261.e1 |
| Nelson, Caleb P; Hoberman, Alejandro; Shaikh, Nader et al. (2016) Antimicrobial Resistance and Urinary Tract Infection Recurrence. Pediatrics 137: |
| Mattoo, Tej K; Chesney, Russell W; Greenfield, Saul P et al. (2016) Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial. Clin J Am Soc Nephrol 11:54-61 |
| Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Predictors of Antimicrobial Resistance among Pathogens Causing Urinary Tract Infection in Children. J Pediatr 171:116-21 |
| Schwaderer, Andrew L; Wang, Huanyu; Kim, SungHwan et al. (2016) Polymorphisms in ?-Defensin-Encoding DEFA1A3 Associate with Urinary Tract Infection Risk in Children with Vesicoureteral Reflux. J Am Soc Nephrol 27:3175-3186 |
| Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Recurrent Urinary Tract Infections in Children With Bladder and Bowel Dysfunction. Pediatrics 137: |
| Shaikh, Nader; Mattoo, Tej K; Keren, Ron et al. (2016) Early Antibiotic Treatment for Pediatric Febrile Urinary Tract Infection and Renal Scarring. JAMA Pediatr 170:848-54 |
| Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Utility of sedation for young children undergoing dimercaptosuccinic acid renal scans. Pediatr Radiol 46:1573-8 |
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