Cardiovascular Diseases Clinical Trial
Official title:
Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)
The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse events.
BACKGROUND:
Kawasaki Disease (KD) is an inflammatory vasculitis of unknown etiology that affects infants
and children and can cause coronary artery aneurysms. Standard therapy consists of 2 gm/kg
of intravenous immune globulin plus high-dose aspirin in the acute phase, and low-dose
aspirin in the convalescent phase. Some children do not respond to this therapy, and some
children go on to develop coronary artery aneurysms in spite of aggressive treatment. This
led to the design of this randomized controlled trial to compare a single dose of
intravenous steroids vs. placebo on the background of standard therapy. Recruitment began in
December, 2002 and ended in December, 2004 with nearly 200 patients randomized.
DESIGN NARRATIVE:
This is a randomized controlled trial to compare a single dose of intravenous steroids vs.
placebo on the background of standard therapy
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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