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

Not Applicable

Completed

• Conditions: Viral Bronchiolitis
• Interventions: Procedure: Chest Physiotherapy with Forced Expiratory Technique; Procedure: Nasopharyngeal Aspiration

• Registration Number: NCT00125450
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-07-29
• Study First Submitted QC: 2005-07-29
• Study First Posted: 2005-08-01
• Status Verified: 2006-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Last Update Submitted: 2008-05-26
• Last Update Posted: 2008-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Chest Physiotherapy with Forced Expiratory Technique	Chest Physiotherapy with Forced Expiratory Technique
B	Nasopharyngeal Aspiration	Aspiration

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety of the forced expiratory technique	during hospitalisation
Comparison of pulse oxymetry before/after chest physiotherapy	during hospitalisation
Quality of Life Scale	on discharge

Trial Locations

Locations (7)

Antoine Béclère Hospital - Pediatric Department; 🇫🇷 Clamart, France

Jean Verdier Hospital; 🇫🇷 Bondy, France

Robert Debré Hospital; 🇫🇷 Paris, France

Ambroise Paré Hospital; 🇫🇷 Boulogne Billancourt, France

Kremlin Bicetre Hospital; 🇫🇷 Le Kremlin Bicetre, France

Trousseau Hospital; 🇫🇷 Paris, France

Necker - Enfants Malades Hospital; 🇫🇷 Paris, France