Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

Study Overview
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Brief Summary
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The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.

Detailed Description
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Bronchiolitis is the most common lower respiratory viral infection in infants. Nowadays bronchiolitis is the first reason of children hospitalisation worldwide. Symptoms are based on airway inflammation associated to an increased mucus production and cell necrosis leading to a multifactorial airway obstruction. Recommended treatments are supportive care based on oxygenation and rehydration. Airway clearance techniques represented by chest physiotherapy remain controversial. Considering that bronchiolitis impacts respiratory condition in young infants feeding and sleep may be reduced. Evaluating quality of life represented by feeding and sleep in hospitalized infants may be an important outcome in this population. The investigators hypothesized that chest physiotherapy with SET will improve children's quality of life, especially 24 hours food intake and sleep.

Official Title
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Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study

Conditions
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Acute Viral Bronchiolitis

Intervention / Treatment
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* Other: Chest physiotherapy with SET
* Other: Standard Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children under 12 months hospitalized for bronchiolitis chest physiotherapy prescription bronchial obstruction confirmed by physician and respiratory physiotherapist Non-inclusion Criteria : children more than 1 year exclusive breastfeeding or enteral feeding prematurity (gestational age < 35 weeks) cardiac, neurological and pulmonary comorbidity continuous oxygen supplementation or ventilatory support chest physiotherapy contraindications Exclusion Criteria: side effects during chest physiotherapy : bradycardia <100 bpm, oxygen saturation<90%, general state alteration outing, oxygen supplementation or parenteral nutrition less than 24 hours after randomization chest physiotherapy cessation according to family request

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 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: Chest physiotherapy with SET<br>Chest physiotherapy will be provided by a single physiotherapist not involved in outcomes assessment. Airway clearance technique will be Slow Expiratory Technique (SET). SET is a slow modulation of airflow in order to remove bronchial secretions within infants lungs. Experimental group will also benefit for standard medical and non-pharmacological care (e.g Standard Treatment) | Other: Chest physiotherapy with SET<br>* Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)<br>Other: Standard Treatment<br>* Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)<br>|
| Active Comparator: Standard treatment<br>Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices. | Other: Standard Treatment<br>* Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food ingestion | Total Food ingestion within 24 hours after intervention measured by nurses or parents | 24 hours following intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Total Sleep Time | 24 hours following intervention | 
| Sleep quality | Desaturation<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep | 24 hours following intervention | 
| Oxygen saturation | Pulse oximetry monitoring | Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention | 
| Respiratory rate | Pulse oximetry monitoring | Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention | 
| Heart Rate | Pulse oximetry monitoring | Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention | 
| Respiratory Distress | Bronchiolitis Severity Score (described by Gajdos et al. as mentioned in the references). The Bronchiolitis Severity Score involves the calculation and addition of three subscores (age-based respiratory rate scale, score of 1-3; retractions, and wheeze scales, both running from 0 to 3). Total score ranges from 1 to 9, with higher scores indicating greater respiratory distress. | Before intervention ; 5 minutes, 30 minutes and 24 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food intake, Chest physiotherapy, Sleep, Respiratory Distress