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

May 26, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93140
        • Jean Verdier Hospital
      • Boulogne Billancourt, France, 92100
        • Ambroise Paré Hospital
      • Clamart, France, 92140
        • Antoine Béclère Hospital - Pediatric Department
      • Le Kremlin Bicetre, France, 94270
        • Kremlin Bicetre hospital
      • Paris, France, 75019
        • Robert Debre Hospital
      • Paris, France, 75012
        • Trousseau Hospital
      • Paris, France, 75015
        • Necker - Enfants Malades Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Chest Physiotherapy with Forced Expiratory Technique
Procedure: Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
Other Names:
  • A. Chest Physiotherapy with Forced Expiratory Technique
Active Comparator: B
Aspiration
Procedure: Nasopharyngeal Aspiration
Nasopharyngeal Aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: obtention
obtention

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of the forced expiratory technique
Time Frame: during hospitalisation
during hospitalisation
Comparison of pulse oxymetry before/after chest physiotherapy
Time Frame: during hospitalisation
during hospitalisation
Quality of Life Scale
Time Frame: on discharge
on discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Association des Réseaux Bronchiolite

Investigators

  • Principal Investigator: Vincent Gajdos, MD, Assistance Publique - Hôpitaux de Paris
  • Study Director: Philippe Labrune, MD - PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

July 29, 2005

First Submitted That Met QC Criteria

July 29, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Estimate)

May 28, 2008

Last Update Submitted That Met QC Criteria

May 26, 2008

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030421
  • AOM 03123
  • DGS 2004/0276

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Viral Bronchiolitis

Clinical Trials on Chest Physiotherapy with Forced Expiratory Technique

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe