Trials / Terminated
TerminatedNCT02760719
The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis
The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- University Medical Centre Ljubljana · Academic / Other
- Sex
- All
- Age
- 1 Month – 24 Months
- Healthy volunteers
- Not accepted
Summary
This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.
Detailed description
Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids. In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects. Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nebulized 3% hypertonic solution | already described |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2019-07-01
- Completion
- 2019-07-01
- First posted
- 2016-05-04
- Last updated
- 2019-08-05
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT02760719. Inclusion in this directory is not an endorsement.