? Vesico-ureteral reflux (VUR) is a common condition seen among children with urinary tract infection (UTI). VUR is associated with serious conditions including acute pyelonephritis and permanent renal injury, leading to scarring, renal impairment (""""""""reflux nephropathy"""""""") and end-stage renal disease. However, the optimal treatment for VUR remains unclear. Both prophylactic antibiotics and surgical correction have been widely implemented for management of children with VUR, but neither of these has been shown in prospective randomized trials to be superior in outcomes to surveillance, and both may have significant risks. The proposed research will identify the optimal initial management approach for children diagnosed with VUR, by comparing non-intervention (surveillance), prophylactic antibiotics, and surgical correction (endoscopic injection of bulking agent) in a prospective, randomized trial. In a multi-center collaboration of five clinical treatment centers and one data center, over 2 years we will enroll 600 patients with VUR (ages 10 years or less), and follow them for 2.5-4.5 years. This study will identify differences in incidence of UTI, reflux nephropathy, and other outcomes. The Brady Urological Institute and the Division of Pediatric Nephrology at Johns Hopkins Hospital are uniquely suited to the execution of the proposed research, with an integrated multi-disciplinary research team, extensive experience in the design and execution of multi-center clinical research, and substantive clinical caseload and experience in treatment of children with VUR. Much of the current management of VUR is based on case series and anecdotes. The information gained from this research has the potential to dramatically change clinical practice, by providing definitive evidence of the optimal initial management of children with VUR. ? Urinary tract infections in children account for over a million doctor visits per year, and 30,000-40,000 hospitalizations per year. Many of these children have vesico-ureteral reflux (a condition where urine improperly flows backwards out of the bladder toward the kidney), and this may predispose these children to urinary infections. While vesico-ureteral relux [sic] can be corrected surgically, it is unclear whether this is beneficial; this research study will compare several management approaches to vesicoureteral reflux to determine which is best ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK074082-04
Application #
7457885
Study Section
Special Emphasis Panel (ZDK1-GRB-6 (O2))
Program Officer
Moxey-Mims, Marva M
Project Start
2005-09-30
Project End
2010-05-31
Budget Start
2008-06-01
Budget End
2009-05-31
Support Year
4
Fiscal Year
2008
Total Cost
$563,806
Indirect Cost
Name
Johns Hopkins University
Department
Urology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
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
Mathews, Ranjiv; Mattoo, Tej K (2015) The role of antimicrobial prophylaxis in the management of children with vesicoureteral reflux--the RIVUR study outcomes. Adv Chronic Kidney Dis 22:325-30

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