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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)

This study has been completed.
Sponsor:
Collaborator:
Association des réseaux Bronchiolite
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00125450
First received: July 29, 2005
Last updated: May 26, 2008
Last verified: October 2006

July 29, 2005
May 26, 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 ] [ Designated as safety issue: Yes ]
  • delay for obtention of healing defined by all of these parameters at least 8 hours in a row :
  • - normal feeding
  • - specific respiratory distress score lower than one as described in the protocol
  • - normal respiratory rate
  • - pulse oxymétry >94%
Complete list of historical versions of study NCT00125450 on ClinicalTrials.gov Archive Site
  • Safety of the forced expiratory technique [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
  • Comparison of pulse oxymetry before/after chest physiotherapy [ Time Frame: during hospitalisation ] [ Designated as safety issue: Yes ]
  • Quality of Life Scale [ Time Frame: on discharge ] [ Designated as safety issue: No ]
  • - 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Other Name: 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
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.

*   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
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00125450
P030421, AOM 03123, DGS 2004/0276
Yes
Marc LEGRAND, Department Clinical Research of Developpemnt
Assistance Publique - Hôpitaux de Paris
Association des réseaux Bronchiolite
Principal Investigator: Vincent Gajdos, MD AP-HP
Study Director: Philippe Labrune, MD - PhD AP-HP
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