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Completed

NCT Number: NCT00125450

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

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.

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Key information

Conditions

Viral Bronchiolitis Bronchial Diseases Bronchiolitis Bronchiolitis, Viral Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

15 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Verdier Hospital, Bondy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest Physiotherapy with Forced Expiratory Technique

Procedure

Chest Physiotherapy with Forced Expiratory Technique

Other names: A. Chest Physiotherapy with Forced Expiratory Technique

Nasopharyngeal Aspiration

Procedure

Nasopharyngeal Aspiration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association des Réseaux Bronchiolite

Registry information

Official study title

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

Acronym: BRONKINOU

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2005
Registry last updated
May 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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