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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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 ]

Original Primary Outcome:

  • 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


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • - Safety of the Forced Expiratory Technique
  • - Comparison of Pulse Oxymetry before/after Chest physiotherapy
  • - Quality of Life Scale


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 29, 2005
Date Started: September 2004
Date Completion:
Last Updated: May 26, 2008
Last Verified: October 2006