Status:
UNKNOWN
Bronchiolitis All-study, SE-Norway
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Oslo
Ostfold University College
Conditions:
Bronchiolitis
Eligibility:
All Genders
Up to 11 years
Phase:
PHASE4
Brief Summary
Bronchiolitis is a common lower respiratory disease typically affecting infants and children generally younger than 2 years of age. The disease leads to hospital admissions, is a major cause for hospi...
Detailed Description
OVERALL AIMS OF THE STUDY: 1. To compare the efficacy of two common treatments by determining whether inhalation treatment with racemic adrenaline is more effective than saline inhalations in acute b...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- children 0 inclusive 11 months admitted to the hospital with symptoms and signs of acute bronchiolitis during the winter season of 2009-11.
- bronchiolitis as defined on clinical criteria by SDM Court (Post graduate medical journal 1973).
- Clinical score of 4 or more (Kristjansson, Arch.Dis.Child. 1993)
- Exclusion criteria:
- Use of regular inhaled corticosteroids.
- Use of systemic or inhaled corticosteroids within the last 4 weeks.
- Significant cardiac, previous severe or persisting (\>4 weeks) respiratory disease, neurologic, immunologic, oncologic 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, \>1 are.
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00817466
Start Date
January 1 2010
End Date
December 1 2013
Last Update
November 2 2012
Active Locations (9)
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1
Sykehuset Buskerud, Vestre Viken
Drammen, Buskerud, Norway, N-3004
2
Sykehuset Innlandet, Elverum
Elverum, Hedmark, Norway, NO-2409
3
Sykehuset Innlandet, Lillehammer
Lillehammer, Oppland, Norway, N-2609
4
Oslo University Hospital, Rikshospitalet
Oslo, Oslo County, Norway, N-0027