The RIVUR Research Study - The Children's Hospital of ...

For more information about this study at
The Children’s Hospital of Philadelphia
please call:
Katie Tremont, B.S.
Study Coordinator
or
Hilary Turner, MPH
Study Research Assistant
Founded in 1855, The Children's Hospital
of Philadelphia is the birthplace of pediatric
medicinein America. Throughout its rich
history, a passionate spirit of innovation has
driven this renowned institution to pursue
The
RIVUR
Research
Study
Help
lead the way.
Phone: 267-426-5683
E-mail: RIVURstudy@gmail.com.
scientific discovery, establish the highest
standards of patient care and train future
leaders in pediatrics. For a century and a
You may also call the study doctor, Dr. Ron
Keren at 215-590-0167.
Please visit us on the Web at www.rivur.net.
half, Children's Hospital has served as a
haven of hope for countless children and
families worldwide.
www .chop.edu
clinicaltrials.gov
This is a multicenter study funded by:
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Philadelphia, PA 19104-4399
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Clinical
Research at
RIVUR
Randomized Intervention for
Children with Vesicoureteral Reflux

What is Vesicoureteral Reflux (VUR)?
During urination, urine normally flows from the
bladder down through the urethra and out of the
body. In children with VUR, urine also flows in
the wrong direction. This happens when it flows
from the bladder back up through the ureters and
towards the kidneys. VUR is present in 30 to 40
percent of children who have had a urinary tract
infection (UTI). VUR is thought to increase the
risk of developing kidney damage when children
have repeat UTIs. Doctors diagnose VUR using
a special radiology test called a VCUG (voiding
cystourethrogram).
How is VUR normally treated?
Children who have a UTI and are found to have
VUR are usually treated with a small daily dose
of antibiotic to try and prevent repeat UTIs and
kidney damage. However, children on preventive
antibiotics can still get UTIs. Also, there have
been no well-designed research studies to show
that antibiotics are actually helpful in preventing
repeat UTIs or kidney damage. A disadvantage
of taking a daily dose of antibiotic for a long
time is that children can develop resistance to
that antibiotic and may need to take a different
antibiotic to treat future infections. Early
diagnosis and treatment of UTIs may be all that
is needed to prevent damage to the kidneys.
What is the RIVUR research study?
The RIVUR research study is designed to find out
whether preventive antibiotics really add any benefit
in preventing UTIs and kidney damage when
children have close follow-up and early diagnosis
and treatment. To answer this question, half of the
children in the study will be assigned by chance (like
tossing a coin) to take daily dose of antibiotic. The
other half will take a placebo (a liquid that looks
like the antibiotic but has no effect on the body).
All children in the study will receive excellent care
with very close follow-up so that repeat UTIs can
be diagnosed and treated right away. Also, all of
the children will have periodic imaging studies and
blood and urine tests to closely follow their kidney
function.
What happens if I take part in RIVUR?
RIVUR is a two-year study. If you take part, we will
ask you to:
l Give your child the study medication once a
day every day
l Come to 5 study visits (1 visit every 6
months) at either The Children’s Hospital of
Philadelphia or The Children’s Hospital
Specialty Care Center in King of Prussia.
l Be contacted by phone every 2 months to
update us about your child’s health
At ALL RIVUR study visits we will:
l Do a basic physical exam and go over your
child’s recent medical history
l Ask you to complete a short questionnaire
about how UTIs and VUR affect your
child’s quality of life
l Compensate you for your time and travel
At SOME RIVUR study visits we will
l Take pictures of your child’s kidneys
(through a special test called a renal scan) to
look for the development of kidney damage
l Obtain blood and urine to monitor your
child’s kidney function and response to the
study medication
l Obtain a small stool sample to check for the
development of resistant bacteria
l Do a VCUG (voiding cystourethrogram)
at the end of the study to see if the VUR has
decreased or disappeared
Clinical Research at