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Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Information provided by:
New England Research Institutes Identifier:
First received: August 17, 2005
Last updated: March 3, 2014
Last verified: April 2012
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 Intervention Phase
Cardiovascular Diseases
Heart Diseases
Coronary Aneurysm
Drug: Steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

Further study details as provided by New England Research Institutes:

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

Secondary Outcome 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 ]

Enrollment: 199
Study Start Date: December 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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


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.

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Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: Lynn Sleeper, ScD, PI, New England Research Institutes Identifier: NCT00132080     History of Changes
Other Study ID Numbers: 241
U01HL068270 ( US NIH Grant/Contract Award Number )
Study First Received: August 17, 2005
Last Updated: March 3, 2014

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 processed this record on May 25, 2017