BACKGROUND Children with febrile urinary tract infection commonly have vesicoureteral reflux. Because trial results have been limited and inconsistent, the use of antimicrobial prophylaxis to prevent recurrences in children with reflux remains controversial. METHODS In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infection, we evaluated the efficacy of trimethoprim–sulfamethoxazole prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance. RESULTS Recurrent urinary tract infection developed in 39 of 302 children who received prophylaxis as compared with 72 of 305 children who received placebo (relative risk, 0.55; 95% confidence interval [CI], 0.38 to 0.78). Prophylaxis reduced the risk of recurrences by 50% (hazard ratio, 0.50; 95% CI, 0.34 to 0.74) and was particularly effective in children whose index infection was febrile (hazard ratio, 0.41; 95% CI, 0.26 to 0.64) and in those with baseline bladder and bowel dysfunction (hazard ratio, 0.21; 95% CI, 0.08 to 0.58). The occurrence of renal scarring did not differ significantly between the prophylaxis and placebo groups (11.9% and 10.2%, respectively). Among 87 children with a first recurrence caused by Escherichia coli, the proportion of isolates that were resistant to trimethoprim–sulfamethoxazole was 63% in the prophylaxis group and 19% in the placebo group. CONCLUSIONS Among children with vesicoureteral reflux after urinary tract infection, antimicrobial prophylaxis was associated with a substantially reduced risk of recurrence but not of renal scarring. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; RIVUR ClinicalTrials.gov number, NCT00405704.)

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Objective To determine factors associated with parental consent for their child’s participation in a randomized, placebo-controlled trial. Design Cross-sectional survey. Setting 7 Children’s Hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux; July 2008 to May 2011. Participants Parents asked to provide consent for their child’s participation in the trial were invited to complete an anonymous online survey about factors influencing their decision. 120 (44%) of the 271 invited, completed the survey: 58 of 125 (46%) had provided and 62 of 144 (43%) had declined consent. Outcome Measures 60-question survey examining: child, parent, and study characteristics; parental perception of the study; understanding of design; external influences; and decision-making process. Results Having graduated from college and private health insurance were associated with lower likelihood of providing consent. Parents who perceived the trial as having low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care or exhibiting potential for enhanced care or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of randomization process, blinding, and right to withdraw were significantly associated with consent to participate. Conclusions Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty.

OBJECTIVETo identify genetic and nongenetic factors contributing to the risk of bladder exstrophyepispadias complex (BEEC). PATIENTS AND METHODSIn all, 285 families with BEEC were invited to participate in the study, and 232 of them were recruited. Epidemiological information was obtained from 151 of the consenting families, with a detailed clinical genetic examination of 94 probands. In all, 440 DNA samples were collected from 163 families for molecular analysis.