Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3% Inhalations

Study Overview
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Brief Summary
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Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.

Detailed Description
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Acute viral bronchiolitis is the most common lower respiratory tract infection in the first year of life and leads to a large number of hospital admissions. The only recommended treatment is supportive. However many different types of drug inhalations have been studied but their efficacy remains controversial. Our study will compare recommended supportive therapy to supportive therapy combined to hypertonic saline (NaCl 3%) inhalations in the treatment of moderate to severe bronchiolitis. This will be the first study to use a true control group with no inhalation.

Official Title
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Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%

Conditions
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Moderate to Severe Bronchiolitis

Intervention / Treatment
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* Drug: NaCl 3%
* Other: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children between ages 6 weeks to 24 months first episode of wheezing diagnosis of moderate to severe bronchiolitis: The patients are ranked as moderately to severely ill according to the Wang clinical severity score Exclusion Criteria: Children with mild bronchiolitis (Wang score < 5) Children with pre-existent cardiac disease Children with clinically significant chronic respiratory disease Immunocompromised children Children with a gestational age at birth less than 34 weeks Children who received immunoprophylaxis therapy (i.e RSV immune globulin therapy) Children who received corticosteroid in any form in the preceding 2 weeks before presentation Children who received bronchodilators within 24 hours before presentation Children with critical illness at presentation requiring immediate admission to intensive care unit

Ages Eligible for Study
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Minimum Age: 6 Weeks
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 |
| --- | --- |
| Active Comparator: NaCl 3% inhalations + standard therapy<br>In this group, patients receive NaCl 3% inhalations ( 4ml QID) together with standard therapy. Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed. | Drug: NaCl 3%<br>* NaCl 3%: 4ml QID<br>* Other names: Mucoclear 3%;Other: Standard therapy<br>* Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed<br>|
| Placebo Comparator: Standard therapy<br>Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed | Other: Standard therapy<br>* Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay | The length of stay is defined as the time between study entry and the time at which the child reach protocol-defined discharge criteria as measured by the physician in charge. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfer rate to ICU |  | 2 years | 
| readmission rate in the next 7 days following discharge |  | 2 years | 
| Wang clinical severity score evolution |  | 2 years | 
| adverse events |  | 2 years | 
| Patients' ability to feed |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiolitis, Moderate to Severe, Hypertonic saline, NaCl 3% inhalations, Standard therapy, Wang score, in-patients