Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
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|ClinicalTrials.gov Identifier: NCT00132080|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : March 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Infection Coronary Aneurysm||Drug: Steroids||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||199 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
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.
- Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes [ Time Frame: Measured 5 weeks post-randomization ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132080
|Principal Investigator:||Lynn Sleeper, ScD.||New England Research Institutes, Watertown, MA|