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
  Purpose

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.


Condition Intervention
Viral Bronchiolitis
Procedure: Chest Physiotherapy with Forced Expiratory Technique
Procedure: Nasopharyngeal Aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 500
Study Start Date: September 2004
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Chest Physiotherapy with Forced Expiratory Technique
Procedure: Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
Other Name: A. Chest Physiotherapy with Forced Expiratory Technique
Active Comparator: B
Aspiration
Procedure: Nasopharyngeal Aspiration
Nasopharyngeal Aspiration
Other Name: Nasopharyngeal Aspiration

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125450

Locations
France
Jean Verdier Hospital
Bondy, France, 93140
Ambroise Paré Hospital
Boulogne Billancourt, France, 92100
Antoine Béclère Hospital - Pediatric Department
Clamart, France, 92140
Kremlin Bicetre Hospital
Le Kremlin Bicetre, France, 94270
Robert Debré Hospital
Paris, France, 75019
Trousseau Hospital
Paris, France, 75012
Necker - Enfants Malades Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Association des réseaux Bronchiolite
Investigators
Principal Investigator: Vincent Gajdos, MD AP-HP
Study Director: Philippe Labrune, MD - PhD AP-HP
  More Information

Additional Information:
Publications:
Responsible Party: Marc LEGRAND, Department Clinical Research of Developpemnt
ClinicalTrials.gov Identifier: NCT00125450     History of Changes
Other Study ID Numbers: P030421, AOM 03123, DGS 2004/0276
Study First Received: July 29, 2005
Last Updated: May 26, 2008
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Bronchiolitis
Chest Physiotherapy
Forced Expiratory Techniques
Double Blind Trial
Children
Pediatric
RESPIRATORY SYNCYTIAL VIRUS

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014