The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: nebulized 3% hypertonic solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations admission to the hospital Wang CSS between 3 and 9 randomisation within 4 hours of admission Exclusion Criteria: a history or previous episodes of bronchiolitis/bronchitis primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected newborns premature infants born < 36 weeks of gestation oxygen saturation < 85% and patients requiring admission to high dependency or intensive care units at presentation

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertonic saline<br>4 ml of nebulized 3 % hypertonic saline + salbutamol 0,03 ml/kg every 8 hours for the time of hospitalisation and standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) | Drug: nebulized 3% hypertonic solution<br>* already described<br>|
| No Intervention: supportive care<br>Standard supportive care (oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion, provision of fluids, gentle nasal aspiration) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Outcome measure will be assessed in hours, data will be presented through study completion- estimated to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalisation | Actual time to discharge in hours, which could be prolonged for other reasons than just bronchiolitis | 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%). | 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 | 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 | 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 | 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 | 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). | 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. | 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. | through study completion - estimated to 2 years, the patients will be assessed through whole hospitalisation time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3% hypertonic solution, duration of hospitalisation