? Primary vesicoureteral reflux (VUR) is a common problem, occuring [sic] in 8-50% of children with urinary tract infection (UTI). It has the potential for causing irreparable renal damage, particularly [sic] in younger children. Despite the widespread use of antibiotic prophylaxis in children with VUR, there are no placebo-controlled studies demonstrating its clinical benefit in preventing renal injury. The main aim of our proposed double blind, placebo-controled [sic] study is to test the hypothesis that prolonged antibiotic prophylaxis in children > 2 years old with grade I-IV VUR is unnecessary. Our study, which is a joint effort of 28 Pediatric Nephrologists and 9 Pediatric Urologists from 28 centers affiliated with the North American Pediatrics Renal Transplant Registry (NAPRTCS) and the Midwest Pediatric Nephrology Consortium (MWPNC) will test this hypothesis by recruiting 120 children up to the age of 10 years with newly diagnosed grades I-IV VUR. We propose using antibiotic prophylaxis in all eligible subjects up to the age of 2 years or a minimum of 6 months from the diagnosis of VUR (whichever comes later) and subsequently randomizing them into prophylaxis and placebo groups. Children >2 years old will be randomized directly at study entry into prophylaxis and placebo groups. Followup will include biannual clinc [sic] visits; yearly renal imaging, blood and urine tests, and assessment for dysfunctional voiding (DV) and constipation; and the measurement of glomerular filtration rate by iohexol clearance. By randomization, we will test our first hypothesis that antibiotic prophylaxis after age 2 years does not decrease the frequency of UTI, reduce the risk of renal scarring, or enhance resolution of VUR. By using objecitve [sic] scoring for DV and constipation, we will test our second hypothesis that their presence delays resolution of VUR, and increases the frequency of UTI and renal scarring, irrespective of long-term antibiotic prophylaxis. Patients who fail medical management will be randomized into Delfux or surgical reimplantation groups to test our third hypothesis that the two treatments do not differ in cure rate, recurrence rate of UTI, or risk of renal scarring. ? Vesicoureteral reflux, the abnormal flow of urine from the bladder into the kidneys, is common in children and may cause kidney damage and high blood pressure. Current treatment uses daily antibiotics for years, but this may not be necessary and may cause some harm, inlcuding [sic] resistance to antibiotics, requiring children to have expensive and painful radiology tests and surgical procedures, and causing parental anxiety. This study will determine if long-term antibiotics are necessary in children with VUR ? ?
| 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 |
| Mattoo, Tej K; Carpenter, Myra A; Moxey-Mims, Marva et al. (2015) The RIVUR trial: a factual interpretation of our data. Pediatr Nephrol 30:707-12 |
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