Clinical Trial: Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)
Brief Summary: 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.
Detailed Summary:
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
Sponsor: New England Research Institutes
Current Primary Outcome: Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes [ Time Frame: Measured 5 weeks post-randomization ]
Original Primary Outcome:
Current Secondary Outcome: 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 ]
Original Secondary Outcome:
Information By: New England Research Institutes
Dates:
Date Received: August 17, 2005
Date Started: December 2002
Date Completion:
Last Updated: March 3, 2014
Last Verified: April 2012
