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Clinical Trials/NCT00125450
NCT00125450
Completed
N/A

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

Assistance Publique - Hôpitaux de Paris7 sites in 1 country500 target enrollmentSeptember 2004

Overview

Phase
N/A
Intervention
Not specified
Conditions
Viral Bronchiolitis
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
500
Locations
7
Primary Endpoint
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
Status
Completed
Last Updated
17 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
September 2004
End Date
February 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Safety of the forced expiratory technique(during hospitalisation)
  • Comparison of pulse oxymetry before/after chest physiotherapy(during hospitalisation)
  • Quality of Life Scale(on discharge)

Study Sites (7)

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