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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
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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
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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

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Arms and Interventions
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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
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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
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Ages Eligible for Study:   15 Days 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
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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
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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
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Principal Investigator: Vincent Gajdos, MD Assistance Publique - Hôpitaux de Paris
Study Director: Philippe Labrune, MD - PhD Assistance Publique - Hôpitaux de Paris
More Information
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Additional Information:

Publications:

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

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Responsible Party: Marc LEGRAND, Department Clinical Research of Developpemnt
ClinicalTrials.gov Identifier: NCT00125450    
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:
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Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Virus Diseases