Trial of Pulse Steroid Therapy in Kawasaki Disease–Pediatric Heart Network
Overview
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.
Full Title of Study: “Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: March 2005
Detailed Description
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
Interventions
- Drug: Steroids
- 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.
Arms, Groups and Cohorts
- Placebo Comparator: 1
- Patients with acute Kawasaki disease
Clinical Trial Outcome Measures
Primary Measures
- Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes
- Time Frame: Measured 5 weeks post-randomization
Secondary Measures
- 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
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 6 Months
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Carelon Research
- Collaborator
- National Heart, Lung, and Blood Institute (NHLBI)
- Provider of Information About this Clinical Study
- Lynn Sleeper, ScD, PI, New England Research Institutes
- Overall Official(s)
- Lynn Sleeper, ScD., Principal Investigator, New England Research Institutes, Watertown, MA
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.