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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Sant Joan de Déu
• Treatments: Glucocorticoids; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

The study will recruit paediatric patients younger than one year old who require hospitalization for moderate-severe bronchiolitis according to the BRONCHIOLITIS SCORE of Sant Joan de Deu Hospital (HSJD)

Exclusion Criteria:

• Patients of either gender under one year old with mild bronchiolitis.

• Patients with bronchiolitis in which the principal symptom is apnoea.

• Patients who have received corticotherapy before admission to hospital.

• No consent from parents or tutors.

• Patients with previous acquired or innate immunodepression.

• Patients enrolled in other clinical trials.