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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Infection Coronary Aneurysm Drug: Steroids Phase 3

Detailed Description:


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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Trial of Pulse Steroid Therapy in Kawasaki Disease (A Trial Conducted by the Pediatric Heart Network)
Study Start Date : December 2002
Primary Completion Date : March 2005
Study Completion Date : March 2005

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Patients with acute Kawasaki disease
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.
Other Name: pulse steroid therapy.

Outcome Measures

Primary Outcome Measures :
  1. Compare the effect of IVMP plus IVIG to IVIG alone on coronary artery outcomes [ Time Frame: Measured 5 weeks post-randomization ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features:

    1. Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips
    2. Polymorphous exanthema
    3. Bilateral, painless bulbar conjunctival injection without exudates
    4. Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
    5. Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral;


  • Patients with at least four days of fever and coronary artery disease, defined as either:

    1. Having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of > 2.5 detected by 2-dimensional echocardiography, as well as:

  • For patients under six months of age, at least two principal criteria
  • For patients at least six months of age, at least three principal criteria. 2. Meeting Japanese Ministry of Health criteria for coronary aneurysm defined as an internal lumen diameter of >3 mm in children less than 5 years of age or >4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion.

AND Enrollment within ten days of the onset of illness, with Day 1 defined as the first day of fever AND Informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Principal Investigator: Lynn Sleeper, ScD. New England Research Institutes, Watertown, MA
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynn Sleeper, ScD, PI, New England Research Institutes
ClinicalTrials.gov Identifier: NCT00132080     History of Changes
Other Study ID Numbers: 241
U01HL068270 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2005    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: April 2012

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Cardiovascular Diseases
Heart Diseases
Coronary Aneurysm
Vascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Coronary Disease
Myocardial Ischemia