Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

Study Overview
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Brief Summary
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The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).

Official Title
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Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

Conditions
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Acute Viral Bronchiolitis

Intervention / Treatment
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* Device: nebulisations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant of less than 18 months old infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage) Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points. absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care signature of the Informed consent Membership in a national insurance Exclusion Criteria: Refusal of the parents to participate in the study 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4. signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas histories of bronchiolitis or asthma of the infant cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age. child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: conventional jet-nebulizer<br>(particles diameter of 4-5 µm) | Device: nebulisations<br> <br> |
| Experimental: a jet-nebulizer adapted for infants<br>(particles diameter of 2-2.5 µm), | Device: nebulisations<br> <br> |
| Experimental: a mesh-nebulizer adapted for infants<br>(particles diameter of 2-2.5 µm). | Device: nebulisations<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement of the clinical score of severity at the 48th hour between the 3 groups of children |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of children requiring oxygen |  | 12 months | 
| tolerance of the nebulisations |  | 12 months | 
| the number of complications. |  | 12 months | 
| the number of parenteral nutrition |  | 12 months |