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The effect of corticosteroid on the treatment of Kawasaki

Evaluation of primary intravenous methyl prednisolone pulse treatment in the prevention of coronary artery abnormality in children with Kawasaki disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181202041817N1
Enrollment
60
Registered
2019-08-26
Start date
2019-02-19
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease. Mucocutaneous lymph node syndrome [Kawasaki]

Interventions

Intervention 1: Intervention group: Aspirin 30 mg / kg and intravenous methyl prednisolone pulse at 30 mg / kg in three days .Within 12 hours after the first dose of the steroid pulse, if the tempera

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 5 Years

Inclusion criteria

Inclusion criteria: Kawasaki disease definition according to American Heart Assosiation (AHA): Complete Kawasaki disease : Fever for more than 5 days plus at least four of the following clinical signs : Bilateral conjunctival injection, Changes in the oropharyngeal mucous membranes, including one or moreof injected and/or fissured lips, strawberry tongue, injected pharynx ,Changes in the peripheral extremities, including erythema and/or edema of the hands and feet (acute phase) or periungual desquamation (convalescent phase), Polymorphous rash, Cervical lymphadenopathy with at least one node >1.5 cm Incomplete Kawasaki : Fever for more than 5 days plus fewer than 4 of the principal clinical findings, and compatible laboratory or echocardiographic findings.

Exclusion criteria

Exclusion criteria: Complicated disease( Macrophage Activating Syndrome) Patients with frequent KD Patients with Coronary Artery Abnormality have already been approved Congestive Heart Failure Chronic renal failure Sensitization to Methyl Prednisolone or Prednisolone Active viral viral zoster infection; or exposure to Varicella in the past 21 days if not safe Injection of Oral, Intravenous or Muscular Corticosteroids> 3 days in the last 7 days History of severe reaction to the preparation of any human globulin product Registering in another study that may affect the effects of treatment, effectiveness, or follow-up.

Design outcomes

Primary

MeasureTime frame
Coronary Artery abnormality in the Kawasaki disease. Timepoint: Echocardiography is performed at least three times (immediately at the beginning of the diagnosis, two weeks and two months after the onset of the disease). Method of measurement: Echocardiography.;Reduction of Coronary Artery abnormality in the Kawasaki disease. Timepoint: Echocardiography is performed at least three times (immediately at the beginning of the diagnosis, two weeks and two months after the onset of the disease). Method of measurement: Echocardiography.

Secondary

MeasureTime frame
The severity of coronary artery disease. Timepoint: At least three times (immediately at the start of the diagnosis, two weeks and two months after the onset of the disease). Method of measurement: Echocardiography.;Prevalence of coronary artery involvement. Timepoint: before intervention, 14 and 60 days after onset of treatment. Method of measurement: echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Vahid Ziaee

Tehran University of Medical Sciences

ziaee@tums.ac.ir+98 21 6659 5522

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026