RIVUR - Randomized Intervention for Children with Vesicoureteral Reflux

RIVUR - 膀胱输尿管反流儿童的随机干预

• 批准号: 8123305
• 负责人: ALEJANDRO HOBERMAN
• 金额: $ 80.95万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123305
• 关键词: Child; Clinical; Data Collection; Enrollment; Funding; Intervention; Patients; Pediatric Hospitals; Procedures; Protocols documentation; Randomized; Recruitment Activity; Role; Site; Time; Vesico-Ureteral Reflux; follow-up

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.

我们正在申请继续担任膀胱输尿管反流儿童随机干预（RIVUR）研究（RFA-DK-09-502）的五个现有临床协调中心（CCC）之一。RIVUR试验尚未达到完全招募，预计这一拟议的3年延长期将允许完全招募和随访原始方案中拟议的600名儿童。征聘工作预计将于2011年5月完成，以便所有后续程序可于2013年5月完成。到目前的资助期结束时（2010年5月），我们预计将有120名儿童参加匹兹堡儿童医院（CHP）CCC。额外的3年延长期将使我们能够（1）继续随访已入组的儿童，完成整个2年随访期，以及（2）招募和随访额外的30名儿童。考虑到我们迄今为止的平均入组率（每月3.5名儿童），我们预计在扩展期的前9-12个月内入组这30名儿童，使我们有足够的时间完成这些患者的2年随访。在RIVUR研究中，CHP CCC已清楚证明其招募、保留和完成儿童随访的能力。到目前为止，我们已经入组了100/373名儿童入组RIVUR，我们是入组研究儿童最多的单一研究中心;最接近的单一研究中心入组了49名儿童。在整个研究过程中，完成数据收集表的总体比率超过95%，证明了我们对儿童的保留。