drugset / Trial / NCT00132080
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network
Phase 3
Completed
199 enrolled
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI) · collabPediatric Heart Network · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2002-12
- Primary completion
- 2005-03
- Completion
- 2005-03
Publications
- Printz BF, Sleeper LA, Newburger JW, Minich LL, Bradley T, Cohen MS, Frank D, Li JS, Margossian R, Shirali G, Takahashi M, Colan SD; Pediatric Heart Network Investigators. Noncoronary cardiac abnormalities are associated with coronary artery dilation and with laboratory inflammatory markers in acute Kawasaki disease. J Am Coll Cardiol. 2011 Jan 4;57(1):86-92. doi: 10.1016/j.jacc.2010.08.619.
- Sleeper LA, Minich LL, McCrindle BM, Li JS, Mason W, Colan SD, Atz AM, Printz BF, Baker A, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Evaluation of Kawasaki disease risk-scoring systems for intravenous immunoglobulin resistance. J Pediatr. 2011 May;158(5):831-835.e3. doi: 10.1016/j.jpeds.2010.10.031. Epub 2010 Dec 18.
- Baker AL, Lu M, Minich LL, Atz AM, Klein GL, Korsin R, Lambert L, Li JS, Mason W, Radojewski E, Vetter VL, Newburger JW; Pediatric Heart Network Investigators. Associated symptoms in the ten days before diagnosis of Kawasaki disease. J Pediatr. 2009 Apr;154(4):592-595.e2. doi: 10.1016/j.jpeds.2008.10.006. Epub 2008 Nov 28.
- Newburger JW, Sleeper LA, McCrindle BW, Minich LL, Gersony W, Vetter VL, Atz AM, Li JS, Takahashi M, Baker AL, Colan SD, Mitchell PD, Klein GL, Sundel RP; Pediatric Heart Network Investigators. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease. N Engl J Med. 2007 Feb 15;356(7):663-75. doi: 10.1056/NEJMoa061235.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 30 mg/kg | Intravenous |