Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.

Detailed Description
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Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the majority of hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence against the effectiveness of chest physiotherapy with vibration and postural drainage techniques has been described but forced expiratory technique, as described in France, has never been evaluated. The investigators hypothesised that forced expiratory technique was able to reduce the duration of respiratory distress. Comparison(s): The investigators compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions.

Official Title
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Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers

Conditions
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Viral Bronchiolitis

Intervention / Treatment
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* Procedure: Chest Physiotherapy with Forced Expiratory Technique
* Procedure: Nasopharyngeal Aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child aged 15 days to 24 months First acute bronchiolitis Indication of hospitalisation One or more of these criteria : toxic aspect; apnea or cyanosis; respiratory rate > 60/min; pulse oxymetry < 95%; alimentary intake < 2/3 of the needs. Exclusion Criteria: Prematurity (gestational age < 32 weeks) Brondysplasia Chronic lung disease or congenital heart disease Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU) 3 or more chest physiotherapy procedures since hospitalisation Parental refusal Any chest physiotherapy contra-indication

Ages Eligible for Study
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Minimum Age: 15 Days
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chest Physiotherapy with Forced Expiratory Technique | Procedure: Chest Physiotherapy with Forced Expiratory Technique<br>* Chest Physiotherapy with Forced Expiratory Technique<br>* Other names: A. Chest Physiotherapy with Forced Expiratory Technique;|
| Active Comparator: B<br>Aspiration | Procedure: Nasopharyngeal Aspiration<br>* Nasopharyngeal Aspiration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate |  | obtention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the forced expiratory technique |  | during hospitalisation | 
| Comparison of pulse oxymetry before/after chest physiotherapy |  | during hospitalisation | 
| Quality of Life Scale |  | on discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Bronchiolitis, Chest Physiotherapy, Forced Expiratory Techniques, Double Blind Trial, Children, Pediatric, RESPIRATORY SYNCYTIAL VIRUS