BRONCHIOLITIS, OPTIMAL TREATMENT IN INFANTS AND PROGNOSIS

Phase 1

Conditions: Acute bronchiolitis
MedDRA version: 12.0Level: LLTClassification code 10000686Term: Acute bronchiolitis

Registration Number: EUCTR2009-012667-34-NO

Lead Sponsor: Oslo University Hospital - Ullevål

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Bronchiolitis as defined on clinical criteria by Court (nasal flaring, tachypnoea, dyspnoea, chest recessions, crepitations and sometimes sibiliations.). Clinical score of 4 or more (see amendment). Age <7 months.
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

Significant cardiac, previous severe or persisting (>4 weeks) respiratory disease, neurological or other disease that may significantly influence the outcomes, including Down’s syndrome. Prematurity per se is not a reason for exclusion. One single previous mild-moderate episode suspect of bronchial obstruction is not an exclusion criterion.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of two common bronchiolitis treatments. This is done by determining whether inhalation of racemic adrenaline is more effective than saline inhalations in children younger than 7 months. Efficacy will be determined for the entire hospital admission. ;Secondary Objective: To define the optimal inhalation treatment intervals (on demand vs predetermined by attending physician).;Primary end point(s): Completion of the study at discharge + possible re-admission according to protocol. <br>Need for intensive care management or assisted ventilation (CPAP-Ventilator) in which treatment failure is considered, and open management is implemented. <br><br>Additional treatment failure is considered as deemed appropriate by the attending physician. <br>

Secondary Outcome Measures