The RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux.

TitleThe RIVUR trial: profile and baseline clinical associations of children with vesicoureteral reflux.
Publication TypeJournal Article
Year of Publication2013
AuthorsCarpenter MA, Hoberman A, Mattoo TK, Mathews, iv R, Keren R, Chesney RW, Moxey-Mims M, Greenfield SP
Corporate AuthorsRIVUR Trial Investigators
JournalPediatrics
Volume132
Issue1
Paginatione34-45
Date Published2013 Jul
ISSN1098-4275
KeywordsAnti-Infective Agents, Urinary, Child, Preschool, Cohort Studies, Cross-Sectional Studies, Double-Blind Method, Female, Humans, Infant, Kidney Cortex, Long-Term Care, Male, Mass Screening, Patient Selection, Prospective Studies, Secondary Prevention, Technetium Tc 99m Dimercaptosuccinic Acid, Trimethoprim, Sulfamethoxazole Drug Combination, Ultrasonography, United States, Urinary Tract Infections, Urography, Vesico-Ureteral Reflux
Abstract

BACKGROUND AND OBJECTIVE: Vesicoureteral reflux (VUR) is diagnosed in ∼30% to 40% of children who have imaging studies after urinary tract infections (UTIs). Our goal is to characterize children enrolled in the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) trial and to compare our study cohort with those from previously published studies.

METHODS: RIVUR investigators from 19 pediatric sites in the United States recruited 607 children with grade I through IV VUR. Children were enrolled after a first or second UTI. This cross-sectional report of baseline data includes extensive clinical, parental report, and imaging study results.

RESULTS: RIVUR recruited 607 children (558 girls, 49 boys) with grade I (11%), II (42%), III (38%), or IV (8%) reflux. The median age was 12 months, and most children (91%) were enrolled after their first UTI. The UTI leading to enrollment was both febrile and symptomatic for 323 children, febrile only in 197 children, and symptomatic only in 86. Renal involvement at baseline as documented by a (99m)Tc dimercaptosuccinic acid scan was uncommon with cortical defects identified in 89 (15%) children. Bladder and bowel dysfunction was identified in 71 (56%) of 126 toilet-trained subjects assessed.

CONCLUSIONS: RIVUR is the largest prospective, randomized trial for children with primary VUR to date, comparing prophylaxis with placebo. The study sample comprises patients from 19 pediatric clinical sites in the United States, whose demographic and clinical characteristics may differ from those of children enrolled in previous trials from other countries.

DOI10.1542/peds.2012-2301
Alternate JournalPediatrics
PubMed ID23753091
PubMed Central IDPMC3691529
Grant ListK23 DK088943 / DK / NIDDK NIH HHS / United States
U01 DK074053 / DK / NIDDK NIH HHS / United States
U01 DK074059 / DK / NIDDK NIH HHS / United States
U01 DK074062 / DK / NIDDK NIH HHS / United States
U01 DK074063 / DK / NIDDK NIH HHS / United States
U01 DK074064 / DK / NIDDK NIH HHS / United States
U01 DK074082 / DK / NIDDK NIH HHS / United States
UL1 TR000005 / TR / NCATS NIH HHS / United States
UL1 TR000128 / TR / NCATS NIH HHS / United States
UL1TR000003 / TR / NCATS NIH HHS / United States