Moderate to Severe Bronchiolitis
Conditions
Keywords
Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients
Brief summary
Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.
Detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial. Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.
Interventions
DRUGNaCl 3%
NaCl 3%: 4ml QID
OTHERStandard therapy
Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
Sponsors
Swiss Foundation for the Health of Children and Adolescents
Raphaelle Jaquet-Pilloud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 24 Months
Healthy volunteers
No
Inclusion criteria
* children between ages 6 weeks to 24 months * first episode of wheezing * diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score
Exclusion criteria
* Children with mild bronchiolitis (Wang score \< 5) * Children with pre-existent cardiac disease * Children with clinically significant chronic respiratory disease * Immunocompromised children * Children with a gestational age at birth less than 34 weeks * Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy) * Children who received corticosteroid in any form in the preceding 2 weeks before presentation * Children who received bronchodilators within 24 hours before presentation * Children with critical illness at presentation requiring immediate admission to intensive care unit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | 2 years | The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge. |
Secondary
| Measure | Time frame |
|---|---|
| transfer rate to ICU | 2 years |
| readmission rate in the next 7 days following discharge | 2 years |
| Wang clinical severity score evolution | 2 years |
| adverse events | 2 years |
| Patients' ability to feed | 2 years |
Countries
Switzerland
Outcome results
None listed