Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU) - Full Text View

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:

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

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

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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
Necker - Enfants Malades Hospital
Paris, France, 75015
Robert Debré Hospital
Paris, France, 75019
Trousseau Hospital
Paris, France, 75012

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:

sponsor web site This link exits the ClinicalTrials.gov site

Publications:

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. Update in: Cochrane Database Syst Rev. 2007;(1):CD004873.


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

ClinicalTrials.gov processed this record on February 25, 2015