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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Viral Bronchiolitis

Treatments: Procedure: Nasopharyngeal Aspiration; Procedure: Chest Physiotherapy with Forced Expiratory Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00125450

P030421

DGS 2004/0276

AOM 03123

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: All

Ages: 15 days to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups

A

Experimental group

Description:

Chest Physiotherapy with Forced Expiratory Technique

Treatment:

Procedure: Chest Physiotherapy with Forced Expiratory Technique

B

Active Comparator group

Description:

Aspiration

Treatment:

Procedure: Nasopharyngeal Aspiration