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Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis

Not Applicable
Completed
Conditions
Acute Viral Bronchiolitis
Interventions
Other: Chest physiotherapy with SET
Other: Standard Treatment
Registration Number
NCT03738501
Lead Sponsor
Groupe Hospitalier du Havre
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
42
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Chest physiotherapy with SETChest physiotherapy with SETChest 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)
Chest physiotherapy with SETStandard TreatmentChest 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)
Standard treatmentStandard TreatmentMedical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.
Primary Outcome Measures
NameTimeMethod
Food ingestion24 hours following intervention

Total Food ingestion within 24 hours after intervention measured by nurses or parents

Secondary Outcome Measures
NameTimeMethod
Sleep quality24 hours following intervention

Desaturation\<90% (Pulse oximetry monitoring during sleep) count during diurnal and nocturnal sleep

Oxygen saturationBefore intervention ; 5 minutes, 30 minutes and 24 hours after intervention

Pulse oximetry monitoring

Respiratory DistressBefore intervention ; 5 minutes, 30 minutes and 24 hours after intervention

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.

Respiratory rateBefore intervention ; 5 minutes, 30 minutes and 24 hours after intervention

Pulse oximetry monitoring

Heart RateBefore intervention ; 5 minutes, 30 minutes and 24 hours after intervention

Pulse oximetry monitoring

Trial Locations

Locations (1)

Groupe Hospitalier Du Havre

🇫🇷

Le Havre, France

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