Status:
COMPLETED
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
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 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 ...
Eligibility Criteria
Inclusion
- Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features:
- Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips
- Polymorphous exanthema
- Bilateral, painless bulbar conjunctival injection without exudates
- Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
- Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral;
- OR
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00132080
Start Date
December 1 2002
End Date
March 1 2005
Last Update
March 4 2014
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