title: The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux.
abstract: 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 (99m)Tc 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.
authors.affiliation: Department of Biostatistics, The University of North Carolina, Chapel Hill, NC, USA. myra.carpenter@unc.edu
authors.forename: Myra A
authors.initials: MA
authors.lastname: Carpenter
authors.forename: Alejandro
authors.initials: A
authors.lastname: Hoberman
authors.forename: Tej K
authors.initials: TK
authors.lastname: Mattoo
authors.forename: Ranjiv
authors.initials: R
authors.lastname: Mathews
authors.forename: Ron
authors.initials: R
authors.lastname: Keren
authors.forename: Russell W
authors.initials: RW
authors.lastname: Chesney
authors.forename: Marva
authors.initials: M
authors.lastname: Moxey-Mims
authors.forename: Saul P
authors.initials: SP
authors.lastname: Greenfield
mesh_terms: D000892:Anti-Infective Agents, Urinary / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007672:Kidney Cortex / Q000473:pathology; D008134:Long-Term Care; D008297:Male; D008403:Mass Screening; D018579:Patient Selection; D011446:Prospective Studies; D055502:Secondary Prevention; D019783:Technetium Tc 99m Dimercaptosuccinic Acid; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D014463:Ultrasonography; D014481:United States; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000188:drug therapy*; D014567:Urography; D014718:Vesico-Ureteral Reflux / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D000892:Anti-Infective Agents, Urinary; D019783:Technetium Tc 99m Dimercaptosuccinic Acid; D015662:Trimethoprim, Sulfamethoxazole Drug Combination
keywords: clinical research/trials; renal scarring; urinary tract infections; vesicoureteral reflux (VUR)