THE EFFICACY OF DEXAMETHASONE IN MECHANICALLY VENTILATED CHILDREN WITH LOWER RESPIRATORY TRACT INFECTION CAUSED BY RESPIRATORY SYNCYTIAL VIRUS - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005192-16-IT

Enrollment

230

Registered

2006-03-14

Start date

2005-01-18

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bronchiolitis and pneumonia correlated Rsv-LRTI MedDRA version: 6.1 Level: PT Classification code 10035732

Interventions

Trade Name: DECADRON FOSF. 4MG/1ML IN 1F Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone CAS Number: 2392-39-4 Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Corticosteroids either systemic or inhaled within 2 weeks before inclusion. No informed consent from parents or caretakers.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026