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

NCT00132080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2014-03-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Pediatric Heart Network

    collaborator OTHER

  • Carelon Research

    lead OTHER

Principal Investigators

  • Lynn Sleeper, ScD. · New England Research Institutes, Watertown, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2005-03-31
Completion
2005-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00132080 on ClinicalTrials.gov