ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00125450
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : May 28, 2008
Sponsor:
Collaborator:
Association des réseaux Bronchiolite
Information provided by:
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Viral Bronchiolitis Procedure: Chest Physiotherapy with Forced Expiratory Technique Procedure: Nasopharyngeal Aspiration Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Study Start Date : September 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: A. Chest Physiotherapy with Forced Expiratory Technique
Active Comparator: B
Aspiration
 Procedure: Nasopharyngeal Aspiration
Nasopharyngeal Aspiration


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety of the forced expiratory technique [ Time Frame: during hospitalisation ]
  2. Comparison of pulse oxymetry before/after chest physiotherapy [ Time Frame: during hospitalisation ]
  3. Quality of Life Scale [ Time Frame: on discharge ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125450


Locations
France
Jean Verdier Hospital
Bondy, France, 93140
Ambroise Paré Hospital
Boulogne Billancourt, France, 92100
Antoine Béclère Hospital - Pediatric Department
Clamart, France, 92140
Kremlin Bicetre Hospital
Le Kremlin Bicetre, France, 94270
Trousseau Hospital
Paris, France, 75012
Necker - Enfants Malades Hospital
Paris, France, 75015
Robert Debré Hospital
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
sponsor web site  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marc LEGRAND, Department Clinical Research of Developpemnt
ClinicalTrials.gov Identifier: NCT00125450     History of Changes
Other Study ID Numbers: P030421
AOM 03123
DGS 2004/0276
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: May 28, 2008
Last Verified: October 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Bronchiolitis
Chest Physiotherapy
Forced Expiratory Techniques
Double Blind Trial
 Children
Pediatric
RESPIRATORY SYNCYTIAL VIRUS

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases