drugset / Trial / NCT02571517

Glucocorticoid Therapy Impact on the Inflammatory Response and Clinical Evolution in Patients With Severe Bronchiolitis

NCT02571517

Phase 4 Completed 94 enrolled Fundació Sant Joan de Déu
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to to demonstrate that a 7-day course of systemic glucocorticoids decreases the inflammatory activity of moderate or severe bronchiolitis in paediatric patients compared to the standard treatment. To evaluate the morbidity (regarding to the clinical course: Intensive Pediatric Unit Care unit (PICU) admission, mechanical ventilation, ionotropic support, nosocomial infection, rescue therapy for respiratory failure; duration of PICU stay and hospitalization; and exitus) between the treatment and the control groups.

Timeline

Start
2011-11
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylprednisolone Other / unclassified 2 mg/kg Intravenous
Subject Prednisolone Other / unclassified 2.5 mg/kg Oral

Indications