Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis (BRONCHIOL-EAT)

Groupe Hospitalier du Havre

Status: Completed

Conditions: Acute Viral Bronchiolitis

Treatments: Other: Chest physiotherapy with SET; Other: Standard Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03738501

2018-A01864-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Chest physiotherapy with SET

Experimental group

Description:

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)

Treatment:

Other: Standard Treatment

Other: Chest physiotherapy with SET

Standard treatment

Active Comparator group

Description:

Medical treatment, health education for parents, rhinopharyngeal clearance using isotonic saline solution, advices.

Treatment:

Other: Standard Treatment