Hypertonic Saline for Outpatient Bronchiolitis

Study Overview
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Brief Summary
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We will study if small children who become ill with respiratory distress during the RSV epidemic are better relieved with salbutamol nebulizations diluted in hypertonic (3%), instead of normal (0.9%) saline.

Detailed Description
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In Santiago, Chile, a near collapse of health services is a notorious feature of every winter when vast numbers of small children line for attention because of respiratory distress caused by a probable RSV infection. Our study will examine if nebulized salbutamol diluted in hypertonic (3%), instead of normal (0.9%) saline, provides better relief in outpatients. If hypertonic saline proves safe and effective, the patients could be better managed and the pressure for attention diminished at a low cost, by a simple change in the saline ampule.

Official Title
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Safety and Efficacy of Hypertonic Vrs. Normal Saline as Diluent of Salbutamol to Reduce Respiratory Distress in Outpatients With the Clinical Diagnosis of Bronchiolitis During the RSV Epidemic.

Conditions
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Bronchiolitis, Respiratory Distress

Intervention / Treatment
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* Drug: Inhalation of salbutamol diluted in hypertonic saline
* Drug: Inhalation of salbutamol diluted in normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1 to 24 months Mild to moderate respiratory distress (Tal score below 9) Up to 5 days of respiratory symptoms, including today Expiratory wheezing heard on chest auscultation Indication of salbutamol nebulization treatment by attending physician Exclusion Criteria: Two prior episodes of wheezing Premature birth (below 38 weeks), if below 6 months of age Lobar pneumonia Body temperature above 38 degree Celsius Use of salbutamol during the previous 6 hours Pulse oxymetry reading below 90% Congenital heart disease Chronic pulmonary disease: Asthma, cystic fibrosis, bronchopulmonary dysplasia Other chronic or genetic condition or disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Salbutamol is diluted in hypertonic (3%) saline. | Drug: Inhalation of salbutamol diluted in hypertonic saline<br>* The first of 3 nebulizations of 0.5 mg of Salbutamol is diluted in 3.5 ml of hypertonic (3%) saline. The second and the third are diluted in normal (0.9%) saline.<br>* Other names: Albuterol diluted in hypertonic saline;|
| Active Comparator: 2<br>Salbutamol is diluted in normal (0.9%) saline. | Drug: Inhalation of salbutamol diluted in normal saline<br>* The 3 nebulizations of 0.5 mg of Salbutamol are diluted in 3.5 ml of normal (0.9%) saline.<br>* Other names: Albuterol diluted in normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the respiratory distress score (Tal) between the basal score and the final score after 3 salbutamol nebulizations |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the respiratory distress score (Tal) between the basal score and the first nebulization |  | 15 to 20 minutes | 
| Change in the respiratory distress score (Tal) between the basal score and the second nebulization |  | 15 to 20 minutes after the first nebulization | 
| Change in pulse oxymetry reading between the basal score and after each of the three nebulizations |  | 1 hour | 
| Change in cardiac frequency, irritability, general condition or anything else between the basal score and the first, second and third nebulization |  | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, respiratory distress, hypertonic saline