Not Signed In -
Bronchiolitis |
Chronic Bronchitis |
Clinical Trial: Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
This study is currently recruiting patients.
Verified by Hospital of Paris April 2005
|
Purpose
| Condition | Intervention |
|---|---|
| Viral Bronchiolitis | Procedure: Chest Physiotherapy with Forced Expiratory Technique |
MedlinePlus related topics: Bronchitis; Respiratory Syncytial Virus Infections; Viral Infections
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of Chest Physiotherapy with Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Secondary Outcomes: - Safety of the Forced Expiratory Technique; - Comparison of Pulse Oxymetry before/after Chest physiotherapy; - Quality of Life Scale
Expected Total Enrollment: 500
Study start: September 2004; Expected completion: March 2009
Last follow-up: March 2008; Data entry closure: March 2008
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. We hypothesised that forced expiratory technique were able to reduce the duration of respiratory distress.
Comparison(s): we compare physiotherapy with forced expiratory techniques to simple aspiration of naso-pharyngeal secretions
Eligibility
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 PICU
- 3 or more chest physiotherapy procedures since hospitalisation
- Parental refusal
- Any chest physiotherapy contra-indication
Location and Contact Information
Philippe Labrune, MD - PhD + 33 1 45 37 44 40 philippe.labrune@abc.aphp.fr
France
Antoine Béclère Hospital - Pediatric Department, Clamart, 92140, France; Recruiting
Vincent Gajdos, MD, Principal Investigator
Philippe Labrune, MD - PhD, Sub-Investigator
Francis Perreaux, MD, Sub-Investigator
Pascale Trioche, MD, Sub-Investigator
Guillaume Boon, MD, Sub-Investigator
Laure Clech, MD, Sub-Investigator
Necker - Enfants Malades Hospital, Paris, 75015, France; Recruiting
Véronique Abadie, MD-PHD, Principal Investigator
Christel Chalouhi, MD, Sub-Investigator
Gérard Lenoir, MD, Sub-Investigator
Isabelle Sermet, MD, Sub-Investigator
Mariane De Montalembert, MD, Sub-Investigator
Philippe Jarnouen de Villartay, MD, Sub-Investigator
Christophe Parsy, MD, Sub-Investigator
Rola Abou Taam, MD, Sub-Investigator
Pierre Scheinmann, MD, Sub-Investigator
Jacques de Blic, MD - PhD, Sub-Investigator
Ambroise Paré Hospital, Boulogne-Billancourt, 92100, France; Recruiting
Laurence Bérard, MD, Principal Investigator
Sandrine Baron - Joly, MD, Sub-Investigator
Bertrand Chevallier, MD, Sub-Investigator
Vanina Giacobi, MD, Sub-Investigator
Agnès de Gonneville, MD, Sub-Investigator
Chantal Stheneur, MD, Sub-Investigator
Emmanuelle Lesprit, MD, Sub-Investigator
Cécile Castro, MD, Sub-Investigator
Kremlin Bicetre Hospital, Le Kremlin-Bicetre, 94270, France; Recruiting
Valérie Nouyrigat, MD, Principal Investigator
Isabelle Kone - Paut, MD, Principal Investigator
Brigitte Bader - Meunier, MD, Sub-Investigator
Stéphanie Lorotte, MD, Sub-Investigator
Corinne Guitton, MD, Sub-Investigator
Marion Decobert, MD, Sub-Investigator
Robert Debré Hospital, Paris, 75019, France; Recruiting
Nicole Beydon, MD, Principal Investigator
François Angoulvant, MD, Sub-Investigator
Guillaume Aubertin, MD, Sub-Investigator
Véronique Houdoin, MD, Sub-Investigator
Valérie Soussan-Banini, MD, Sub-Investigator
Mathie Lorrot, MD, Sub-Investigator
Antoine Bourillon, MD, Sub-Investigator
Trousseau Hospital, Paris, 75012, France; Recruiting
Ralph Epaud, MD, Principal Investigator
Annick Clement, MD, Sub-Investigator
Hariet Corvol, MD, Sub-Investigator
Nathalie Guillemot, MD, Sub-Investigator
Corinne Troadec, MD, Sub-Investigator
Nadia Moulin, MD, Sub-Investigator
Stéphanie Vrielynck, MD, Sub-Investigator
Emmanuel Grimprel, MD-PHD, Sub-Investigator
Alexis Mandelcwajg, MD, Sub-Investigator
Nathalie Parez, MD, Sub-Investigator
Thierry Billette, MD-PHD, Sub-Investigator
Alexandra Afenjar, MD, Sub-Investigator
Tim Ulinski, MD, Sub-Investigator
Jean Verdier Hospital, Bondy, 93140, France; Recruiting
Loïc De Pontual, MD, Principal Investigator
Joël Gaudelus, MD, Sub-Investigator
Laurent Balu, MD, Sub-Investigator
Céline Bailly-Botuha, MD, Sub-Investigator
Barbara Tisseron-Maury, MD, Sub-Investigator
Eric Lachassinne, MD, Sub-Investigator
Mireille Nathanson, MD, Sub-Investigator
Anne-Marie Teychene, MD, Sub-Investigator
Emmanuelle Letamendia-Richard, MD, Sub-Investigator
Caroline Belasco, MD, Sub-Investigator
Vincent Gajdos, MD, Principal Investigator, AP - HP
Philippe Labrune, MD - PhD, Study Director, AP - HP
More Information
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.
Last Updated: August 1, 2005
Record first received: July 29, 2005
ClinicalTrials.gov Identifier: NCT00125450
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-08-02
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