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

Viral Bronchiolitis Clinical Trial

— BRONKINOU  

Official title:

Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125450
• Other study ID #: P030421
• Secondary ID: AOM 03123DGS 200
• Status: Completed
• Phase: N/A
• First received: July 29, 2005
• Last updated: May 26, 2008
• Start date: September 2004
• Est. completion date: February 2008

Study information

• Verified date: October 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral
• Viral Bronchiolitis

Intervention

Procedure:
• Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
• Nasopharyngeal Aspiration
Nasopharyngeal Aspiration

Locations

Country	Name	City	State
France	Jean Verdier Hospital	Bondy
France	Ambroise Paré Hospital	Boulogne Billancourt
France	Antoine Béclère Hospital - Pediatric Department	Clamart
France	Kremlin Bicetre Hospital	Le Kremlin Bicetre
France	Necker - Enfants Malades Hospital	Paris
France	Robert Debré Hospital	Paris
France	Trousseau Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Association des réseaux Bronchiolite

Country where clinical trial is conducted

France, 

References & Publications (1)

Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. Review. Update in: Cochrane Database Syst Rev. 2007;(1):CD004873. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Safety of the forced expiratory technique		during hospitalisation	Yes
Secondary	Comparison of pulse oxymetry before/after chest physiotherapy		during hospitalisation	Yes
Secondary	Quality of Life Scale		on discharge	No

External Links

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