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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
already described
Department of infectious disease, University Medical Centre, Ljubljana
Ljubljana, Slovenia
Fit to discharge time
Fit to discharge time: as the point (measured in hours) at which the infant was feeding adequately (taking \>75% of their usual intake) and had been in air with a saturation of at least 92% for 6 h.
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Duration of hospitalisation
Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Duration of hypoxia
For how long (in hours) participants need the oxygen therapy (have saturation on air bellow 92%).
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Clinical severity score (CSS) assessed by Wang score
Wang 1992 CSS as an outcome: measured two times daily
Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants with treatment related adverse events assessed by questionnaire
To asses all possible side effects related to the inhalation of hypertonic saline
Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of participants transferred to the intensive care unit (ICU)
The need to be transferred to the ICU because of the respiratory failure
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Time frame: Through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time
Number of patients readmitted to the hospital because of the same diagnose
Rate of readmission within one month after discharge because of the same disease
Time frame: Through study completion - estimated to 2 years; the patients will be assessed up to one month after discharge
Comparison of fit to discharge time between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
To see if there are any differences in fit to discharge time (the point measured in hours at which the infant was feeding adequately - taking \>75% of their usual intake and had been in air with a saturation of at least 92% for 6 h) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis (to see if hypertonic saline has better effect on fit to discharge time in patients who have RSV bronchiolitis compared to patients who have non-RSV bronchiolitis).
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Comparison of hypoxia duration between patients treated with nebulized hypertonic saline with respiratory syncytial virus (RSV) versus non-RSV bronchiolitis.
To see if there are any differences in hypoxia (for how long in hours participants need the oxygen therapy: have saturation bellow 92%) between patients who received nebulized hypertonic saline and have RSV bronchiolitis and patients who received nebulized hypertonic saline and have non-RSV bronchiolitis.
Time frame: Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years
Number of participants with treatment related adverse events assessed by questionnaire: comparison of patients with RSV bronchiolitis and patients with non-RSV bronchiolitis.
To asses all possible side effects related to the inhalation of hypertonic saline in patients who have RSV bronchiolitis compared to the patients who have non-RSV bronchiolitis.
Time frame: through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time