THE EFFICACY OF DEXAMETHASONE IN MECHANICALLY VENTILATED CHILDREN WITH LOWER RESPIRATORY TRACT INFECTION CAUSED BY RESPIRATORY SYNCYTIAL VIRUS - ND
- Conditions
- bronchiolitis and pneumonia correlated Rsv-LRTIMedDRA version: 6.1Level: PTClassification code 10035732
- Registration Number
- EUCTR2005-005192-16-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
Clinical diagnosis RSV-LRTI first attack of shortness of breath before the age of 2 during RSV season with a positive RSV antigen detection in nasopharyngeal aspirate. Mechanical ventilation through an endotracheal tube
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Corticosteroids either systemic or inhaled within 2 weeks before inclusion. No informed consent from parents or caretakers.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To estimate the effectiveness of corticosteroids dexamethasone in mechanically ventilated children with Rsv-LTRI with classification of patients into the two clinical patterns of bronchiolitis and pneumonia.;Secondary Objective: To estimate the effectiveness of corticosteroids dexamethasone in mechanically ventilated children with Rsv-LTRI with classification of patients into the two clinical patterns of bronchiolitis and pneumonia.;Primary end point(s): Duration of the mechanical ventilation and lenght of stay in the PICU.
- Secondary Outcome Measures
Name Time Method