Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

Keren, Ron; Carpenter, Myra A.; Hoberman, Alejandro; Shaikh, Nader; Matoo, Tej; Chesney, Russell W.; Matthews, Robert; Gerson, Arlene C.; Greenfield, Saul P.; Fivush, Barbara A.; McLurie, Gordon A.; Rushton, H. Gil; Canning, Douglas A.; Nelson, Caleb P.; Greenbaum, L.; Bukowski, Timothy P.; Primack, William A.; Sutherland, Richard W.; Hosking, James D.; Stewart, Dawn; Elder, Jack S.; Moxey-Mims, Marva; Nyberg, Leroy M.

doi:10.1542/peds.2008-1285d

Cited by 109 publications

(72 citation statements)

References 41 publications

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“…Details on methods for patient selection, data collection, and power analysis for the RIVUR trial have been described previously (8,9). The RIVUR trial was a multicenter, randomized, placebo-controlled trial in 607 children aged 2-71 months with grade 1-4 primary VUR diagnosed after a first or second febrile or symptomatic UTI.…”

Section: Methodsmentioning

confidence: 99%

Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial

Mattoo¹,

Chesney²,

Greenfield³

et al. 2016

Clinical Journal of the American Society of Nephrology

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Background and objectives The main objectives of the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial were to evaluate the role of antimicrobial prophylaxis in the prevention of recurrent urinary tract infection (UTI) and renal scarring in children with vesicoureteral reflux (VUR). We present a comprehensive evaluation of renal scarring outcomes in RIVUR trial participants.Design, setting, participants, & measurements This multicenter, randomized, placebo-controlled trial enrolled 607 children aged 2-71 months with grade 1-4 VUR diagnosed after a first or second febrile or symptomatic UTI. Study participants received trimethoprim-sulfamethoxazole or placebo and were followed for 2 years. Renal scarring was evaluated by baseline and follow-up 99m technetium dimercaptosuccinic acid (DMSA) renal scans that were reviewed independently by two blinded reference radiologists.Results At the end of the study, 58 (10%) of 599 children and 63 (5%) of 1197 renal units had renal scarring. New renal scarring did not differ between the prophylaxis and placebo groups (6% versus 7%, respectively). Children with renal scarring were significantly older (median age, 26 versus 11 months; P=0.01), had a second UTI before enrollment (odds ratio [OR], 2.85; 95% confidence interval [95% CI], 1.38 to 5.92), were more likely to be Hispanic (OR, 2.22; 95% CI, 1.13 to 4.34), and had higher grades of VUR (OR, 2.79; 95% CI, 1.56 to 5.0). The proportion of new scars in renal units with grade 4 VUR was significantly higher than in units with no VUR (OR, 24.2; 95% CI, 6.4 to 91.2).Conclusions Significantly more renal scarring was seen in relatively older children and in those with a second episode of febrile or symptomatic UTI before randomization. Preexisting and new renal scars occurred significantly more in renal units with grade 4 VUR than in those with low-grade or no VUR. Antimicrobial prophylaxis did not decrease the risk of renal scarring.

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Section: Methodsmentioning

confidence: 99%

Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial

Mattoo¹,

Chesney²,

Greenfield³

et al. 2016

Clinical Journal of the American Society of Nephrology

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100

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“…The rationale and trial design have been described previously. [2][3][4] Briefly, we enrolled infants and children aged 2 to 71 months with grade I through IV VUR after a first or second febrile or symptomatic UTI. Primary exclusion criteria included index UTI diagnosis .112 days before enrollment, comorbid urologic anomalies (Society of Fetal Ultrasonography grade 4 hydronephrosis with renal parenchyma atrophy, ureterocele, urethral valve, solitary kidney, profoundly small [.2 SD below the mean] kidney, multicystic dysplastic kidney, neurogenic bladder, pelvic kidney, or fused kidney), contraindications for use of trimethoprimsulfamethoxazole, and selected other medical conditions.…”

Section: Methodsmentioning

confidence: 99%

“…Although eligibility was based on local reports for ultrasound and VCUG, images were also assessed by 2 pediatric radiologists using a standardized reading protocol. 4,15 We report these data from the central radiologists. VUR was graded according to the system of the International Reflux Study Group.…”

Section: Data Collectionmentioning

confidence: 99%

The RIVUR Trial: Profile and Baseline Clinical Associations of Children With Vesicoureteral Reflux

et al. 2013

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BACKGROUND AND OBJECTIVE: Vesicoureteral reflux (VUR) is diagnosed in ∼30% to 40% of children who have imaging studies after urinary tract infections (UTIs). Our goal is to characterize children enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial and to compare our study cohort with those from previously published studies. METHODS: RIVUR investigators from 19 pediatric sites in the United States recruited 607 children with grade I through IV VUR. Children were enrolled after a first or second UTI. This cross-sectional report of baseline data includes extensive clinical, parental report, and imaging study results. RESULTS: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%), or IV (8%) reflux. The median age was 12 months, and most children (91%) were enrolled after their first UTI. The UTI leading to enrollment was both febrile and symptomatic for 323 children, febrile only in 197 children, and symptomatic only in 86. Renal involvement at baseline as documented by a 99mTc dimercaptosuccinic acid scan was uncommon with cortical defects identified in 89 (15%) children. Bladder and bowel dysfunction was identified in 71 (56%) of 126 toilet-trained subjects assessed. CONCLUSIONS: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. The study sample comprises patients from 19 pediatric clinical sites in the United States, whose demographic and clinical characteristics may differ from those of children enrolled in previous trials from other countries.

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“…The most recent study to be initiated is a North American initiative: the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) study [18]. It is a double-blind, randomised, placebo-controlled trial, which plans to enroll 600 children, 2-72 months of age, with grades I to IV vesicoureteral reflux after the Table 1 Summary of the four prospective, randomised, controlled trials of antibiotic prophylaxis for preventing febrile urinary tract infections and pyelonephritis published to date (tot total number of randomly chosen patients in each reflux group, + number of children with recurrence of febrile UTIs)…”

mentioning

confidence: 99%

Urinary tract infections: to prophylaxis or not to prophylaxis?

Montini

Hewitt

2009

Pediatr Nephrol

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Urinary tract infections, with or without reflux, are the most frequent reason for long-term antibacterial prophylaxis in infants and children. When one is considering the use of prophylaxis in these children, what is clear from existing published data? Up to 2006 there were a small number of poor quality studies, with no reliable evidence of the effectiveness of antibiotics in preventing recurrent symptomatic urinary tract infections (UTIs). Since then, four randomised controlled studies, to assess the benefits, or lack thereof, of antibiotic prophylaxis, have been published. None has demonstrated a clear benefit. The following conclusions can be drawn: antibiotic prophylaxis is not indicated for children following a first febrile UTI if no or mild grade I or II reflux is present; for higher grade reflux there is no definite conclusion.

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Rationale and Design Issues of the Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR) Study

Cited by 109 publications

References 41 publications

Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial

Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial

The RIVUR Trial: Profile and Baseline Clinical Associations of Children With Vesicoureteral Reflux

Urinary tract infections: to prophylaxis or not to prophylaxis?

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