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Trial record 1 of 1 for:    00125450
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Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU) (BRONKINOU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125450
First Posted: August 1, 2005
Last Update Posted: May 28, 2008
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.
Collaborator:
Association des réseaux Bronchiolite
Information provided by:
Assistance Publique - Hôpitaux de Paris
July 29, 2005
August 1, 2005
May 28, 2008
September 2004
February 2008   (Final data collection date for primary outcome measure)
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 ]
  • delay for obtention of healing defined by all of these parameters at least 8 hours in a row :
  • - pulse oxymétry >94%
  • - normal feeding
  • - specific respiratory distress score lower than one as described in the protocol
  • - normal respiratory rate
Complete list of historical versions of study NCT00125450 on ClinicalTrials.gov Archive Site
  • Safety of the forced expiratory technique [ Time Frame: during hospitalisation ]
  • Comparison of pulse oxymetry before/after chest physiotherapy [ Time Frame: during hospitalisation ]
  • Quality of Life Scale [ Time Frame: on discharge ]
  • - Safety of the Forced Expiratory Technique
  • - Comparison of Pulse Oxymetry before/after Chest physiotherapy
  • - Quality of Life Scale
Not Provided
Not Provided
 
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Viral Bronchiolitis
  • Procedure: Chest Physiotherapy with Forced Expiratory Technique
    Chest Physiotherapy with Forced Expiratory Technique
    Other Name: A. Chest Physiotherapy with Forced Expiratory Technique
  • Procedure: Nasopharyngeal Aspiration
    Nasopharyngeal Aspiration
  • Experimental: A
    Chest Physiotherapy with Forced Expiratory Technique
    Intervention: Procedure: Chest Physiotherapy with Forced Expiratory Technique
  • Active Comparator: B
    Aspiration
    Intervention: Procedure: Nasopharyngeal Aspiration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00125450
P030421
AOM 03123
DGS 2004/0276
Yes
Not Provided
Not Provided
Marc LEGRAND, Department Clinical Research of Developpemnt
Assistance Publique - Hôpitaux de Paris
Association des réseaux Bronchiolite
Principal Investigator: Vincent Gajdos, MD Assistance Publique - Hôpitaux de Paris
Study Director: Philippe Labrune, MD - PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP