Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital stay, oxygen requirements and clinical outcome.

Detailed Description
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Despite bronchiolitis is a very frequent disease among infants, there are still controversies regarding its treatment. Hypertonic saline has been proposed as useful treatment in these children, bur information is still controversial. The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol) may reduce the days of hospitalization and improve clinical outcomes in patients with acute bronchiolitis, compared with using Normal Saline with albuterol.

Official Title
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A Randomized Controlled Trial to Evaluate Efficacy of Nebulized Hypertonic Saline vs. Normal Saline in the Treatment of Hospitalized Children With Bronchiolitis

Conditions
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Bronchiolitis

Intervention / Treatment
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* Drug: Hypertonic saline
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%. Exclusion Criteria: Chronic respiratory or cardiovascular disease, respiratory failure.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

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<br>Nebulized hypertonic saline (sodium chloride 3%) + albuterol | Drug: Hypertonic saline<br>* 3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days<br>* Other names: ClNa 3% (sodium chloride 3%);|
| Active Comparator: Normal<br>Normal saline (sodium chloride 0.9%) + albuterol | Drug: Normal saline<br>* 3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days<br>* Other names: ClNa 0.9% (sodium chloride 0.9%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization Days | hospitalization days | Participants will be followed for the duration of hospitalization, an expected average of 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Oxygen Use | Length of oxygen use (days) | Participants will be followed for the duration of hospitalization, an expected average of 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Hypertonic, Saline, Efficacy