Effect of inhaled hypertonic saline solution to treat infants hospitalized with viral bronchiolitis. - bronchiolitis trial
- Conditions
- Acute viral bronchiolitis (an infection of the lower airways) in infants under two years of age. This is usually caused by Respiratory Syncytial Virus (RSV). The diagnosis of viral bronchiolitis will be made clinically and infants must fulfil the following criteria: prolonged (wheezing) expiration, tachypnoe and dyspnoe, frequently leading to respiratory insufficienty.
- Registration Number
- EUCTR2008-003886-17-NL
- Lead Sponsor
- VieCuri Medisch Centrum voor Noord-Limburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Infants younger than 24 months admitted with a viral bronchiolitis (prolonged and/or wheezing exspiration, tachypnoe and dyspnoe), a Wang-score of two or more and without a positive reaction on Salbutamol inhalation are included, after informed parental consent.
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 are: haemodynamically important congenital cardiac disease, chronic pre-existent respiratory disease, T-cell immunodeficienty and admission of the patient with a viral bronchiolitis not due to clinical reasons, for instance social problems. Infants who are treated with systemic corticosteroids will also be excluded from the study, as are infants suspected to have underlying asthma and/or allergy. This includes infants with eczema or food-allergy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method