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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK074053-08
Application #
8323110
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (M2))
Program Officer
Moxey-Mims, Marva M
Project Start
2005-09-30
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
8
Fiscal Year
2012
Total Cost
$809,549
Indirect Cost
$275,193
Name
University of Pittsburgh
Department
Pediatrics
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Predictors of Antimicrobial Resistance among Pathogens Causing Urinary Tract Infection in Children. J Pediatr 171:116-21
Shaikh, Nader; Hoberman, Alejandro; Keren, Ron et al. (2016) Recurrent Urinary Tract Infections in Children With Bladder and Bowel Dysfunction. Pediatrics 137:
Schwaderer, Andrew L; Wang, Huanyu; Kim, SungHwan et al. (2016) Polymorphisms in α-Defensin-Encoding DEFA1A3 Associate with Urinary Tract Infection Risk in Children with Vesicoureteral Reflux. J Am Soc Nephrol 27:3175-3186
Mattoo, Tej K; Chesney, Russell W; Greenfield, Saul P et al. (2016) Renal Scarring in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) Trial. Clin J Am Soc Nephrol 11:54-61
Schaeffer, Anthony J; Greenfield, Saul P; Ivanova, Anastasia et al. (2016) Reliability of grading of vesicoureteral reflux and other findings on voiding cystourethrography. J Pediatr Urol :
Shaikh, Nader; Wald, Ellen R; Keren, Ron et al. (2016) Predictors Of Non-Escherichia Coli Urinary Tract Infection. Pediatr Infect Dis J 35:1266-1268
Bhatnagar, Sonika; Hoberman, Alejandro; Kearney, Diana H et al. (2014) Development and impact of an intervention to boost recruitment in a multicenter pediatric randomized clinical trial. Clin Pediatr (Phila) 53:151-7
Hoberman, Alejandro (2014) The research home: partnering with families. Acad Pediatr 14:549-53
RIVUR Trial Investigators; Hoberman, Alejandro; Greenfield, Saul P et al. (2014) Antimicrobial prophylaxis for children with vesicoureteral reflux. N Engl J Med 370:2367-76
Chesney, Russell W; Patters, Andrea B (2013) Childhood vesicoureteral reflux studies: registries and repositories sources and nosology. J Pediatr Urol 9:731-7

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