Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

Study Overview
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Brief Summary
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This is a prospective, randomized, controlled, double-blinded, clinical trial Subject : 3mo   24mo. aged infants with bronchiolitis The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.

Detailed Description
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Randomly assigned to one of three groups Group I : nebulized epinephrine + 0.9% saline + placebo Group II : nebulized epinephrine + 3% saline + placebo Group III : nebulized epinephrine + 0.9% saline + dexamethasone Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone. The primary outcome is hospital admission within 7 days after the day of enrollment

Official Title
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Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

Conditions
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Acute Bronchiolitis

Intervention / Treatment
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* Drug: 3% saline + oral placebo
* Drug: 0.9% saline + oral dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3mo   24mo aged patients with bronchiolitis visit to emergency departments RDAI score 4-15 Exclusion Criteria: < 3mo, > 24mo infants who had received oral or inhaled corticosteroids during the preceding 2 weeks infants with a previous episode of wheezing or a diagnosis of asthma any chronic cardiopulmonary disease immunodeficiency infants needed intubation infants with a previous history of apnea or intubation infants with side effect of dexamethasone infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation

Ages Eligible for Study
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Minimum Age: 3 Months
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 |
| --- | --- |
| Placebo Comparator: 0.9% saline + oral placebo<br>nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline | Drug: 0.9% saline + oral dexamethasone<br>* nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline<br>|
| Experimental: 3% saline + oral placebo<br>nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline | Drug: 3% saline + oral placebo<br>* nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline<br>|
| Active Comparator: 0.9% saline + oral dexamethasone<br>nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline | Drug: 0.9% saline + oral dexamethasone<br>* nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital admission within 7 days after the day of enrollment | hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department) | within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDAI score | RDAI score | baseline, between nebulizer, 60min, 120min, 180min, 240min | 
| respiratory rate | respiratory rate | baseline, between nebulizer, 60min, 120min, 180min, 240min | 
| Heart rate | Heart rate | baseline, between nebulizer, 60min, 120min, 180min, 240min | 
| Oxygen saturation | Oxygen saturation | baseline, between nebulizer, 60min, 120min, 180min, 240min | 
| unplanned revisit and admission rate after revisit | unplanned revisit admission rate after revisit | in 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone