Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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 |
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
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 May 23, 2013