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: 8323110
• 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 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323110
• 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.

我们正在申请继续我们作为当前五个临床协调中心(CCCS)之一的角色，在随机干预儿童膀胱输尿管反流(RIVUR)研究(RFA-DK-09-502)中。RIVUR试验尚未达到全面招募，预计这一拟议的3年延期将允许全面招募和跟踪原始议定书中提议的600名儿童。征聘工作预计将于2011年5月完成，以便在2013年5月之前完成所有后续程序。到目前的资助期结束时(2010年5月)，我们预计将为匹兹堡儿童医院(CHP)CCC招收商定的120名儿童。额外的3年延期将使我们能够(1)继续跟踪已经登记的儿童进行完整的2年随访期，以及(2)招募和跟踪额外的30名儿童。鉴于到目前为止我们的平均登记人数(每月3.5名儿童)，我们预计在延长期的前9-12个月内登记这30名儿童，让我们有足够的时间为这些患者完成为期2年的随访。在RIVUR研究中，CHP CCC清楚地展示了它招募、保留和完成对儿童的跟踪调查的能力。到目前为止，我们已经在RIVUR招收了373名儿童中的100名，我们是参与这项研究的儿童人数最多的单一地点；最近的单一地点有49名儿童登记。我们留住儿童的证据是，在整个研究过程中，数据收集表格的总体完成率超过95%。

项目成果

Predictors Of Non-Escherichia Coli Urinary Tract Infection.

• DOI: 10.1097/inf.0000000000001301
• 发表时间: 2016-11
• 期刊: The Pediatric infectious disease journal
• 作者: Shaikh N;Wald ER;Keren R;Gotman N;Ivanova A;Carpenter MA;Moxey-Mims M;Hoberman A
• 通讯作者: Hoberman A