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.

我们正在申请继续担任膀胱输尿管反流儿童随机干预 (RIVUR) 研究 (RFA-DK-09-502) 中现有五个临床协调中心 (CCC) 之一的角色。 RIVUR 试验尚未达到全面招募的阶段，预计拟议的 3 年延期将允许对原始方案中提议的 600 名儿童进行全面招募和随访。招募预计将于 2011 年 5 月完成，以便所有后续程序可于 2013 年 5 月完成。到当前资助期结束时（2010 年 5 月），我们预计将为儿童医院招收商定的 120 名儿童。匹兹堡 (CHP) CCC。额外的 3 年延期将使我们能够 (1) 在整个 2 年随访期内继续跟踪已登记的儿童，以及 (2) 招募和跟踪另外 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 个月内入组这 30 名儿童，以便我们有足够的时间完成对这些患者的 2 年随访。 CHP CCC 在 RIVUR 研究中清楚地展示了其招募、保留和完成儿童随访的能力。迄今为止，我们已在 RIVUR 中招募了 100/373 名儿童，我们是参与该研究的儿童最多的单一中心；最近的一个站点有 49 名儿童注册。我们对儿童的保留率通过整个研究期间数据收集表格的总体完成率超过 95% 得到证明。

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