Trial of Pulse Steroid Therapy in Kawasaki Disease--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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)|
- Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes [ Time Frame: Measured 5 weeks post-randomization ] [ Designated as safety issue: Yes ]
- Occurrence of CA aneurysms; individual z scores of the LMCA, proximal RCA, and proximal LAD CA at 1 and 5 weeks; changes in absolute coronary dimensions for all CA segments from baseline to 1 and 5 weeks after randomization [ Time Frame: Measured 5 weeks post-randomization ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2002|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Patients with acute Kawasaki disease
This study evaluates the efficacy and safety of pulse steroid therapy, when added to conventional treatment with IVIG plus aspirin, in treatment of children with acute Kawasaki disease.
Other Name: pulse steroid therapy.
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.
This is a randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy
|Principal Investigator:||Lynn Sleeper, ScD.||New England Research Institutes, Watertown, MA|