RIVUR - Randomized Intervention for Children with Vesicoureteral Reflux

我们正在申请继续作为目前五个临床协调中心（CCCs）之一参与膀胱输尿管反流儿童随机干预（RIVUR）研究（RFA-DK-09-502）。RIVUR试验尚未达到其全部招募，预计拟议的3年延长将允许完全招募和跟踪原始方案中提议的600名儿童。招聘工作预计将于2011年5月完成，所有后续程序可于2013年5月完成。到当前资助期结束时（2010年5月），我们预计将为匹兹堡儿童医院（CHP） CCC登记约定的120名儿童。额外的3年延长将使我们能够(1)在完整的2年随访期内继续跟踪已经注册的儿童，(2)招募并跟踪另外30名儿童。鉴于我们迄今为止的平均入组率（每月3.5名儿童），我们预计在延长期的前9-12个月入组这30名儿童，给我们足够的时间完成对这些患者的2年随访。在RIVUR研究中，CHP CCC已经清楚地证明了其招募、保留和完成儿童随访的能力。迄今为止，我们在RIVUR招募了100/373名儿童，我们是参与研究的儿童最多的单一站点；最近的一个站点有49个孩子注册。在整个研究过程中，数据收集表格的完成率超过95%，证明了我们对儿童的保留。

We are applying to continue our role as one of the five current Clinical Coordinating Centers (CCCs) in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) study (RFA-DK-09-502). The RIVUR trial has not yet reached its full recruitment and it is anticipated that this proposed 3-year extension will allow for full recruitment and follow-up of the 600 children proposed in the original protocol. Recruitment is expected to be completed by May 2011 so that all follow-up procedures can be completed by May 2013. By end of the current funding period (May 2010), we expect to have enrolled the agreed upon 120 children for the Children's Hospital of Pittsburgh (CHP) CCC. The additional 3-year extension will allow us to (1) continue to follow children already enrolled for the full 2-year follow-up period, and (2) to recruit and follow up to an additional 30 children. Given our mean rate of enrollment to date (3.5 children per month), we expect to enroll these 30 children during the first 9-12 months of the extension period, giving us sufficient time to complete 2-year follow-up for these patients. The CHP CCC has clearly demonstrated its ability to recruit, retain and complete follow-up of children in the RIVUR study. We have enrolled 100/373 children enrolled to date in RIVUR, we are the single site with the most children enrolled in the study; the closest single site has 49 children enrolled. Our retention of children is evidenced by rates above 95% overall in completion of data collection forms throughout the study.