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

Primary Purpose

Viral Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chest Physiotherapy with Forced Expiratory Technique
Nasopharyngeal Aspiration
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Bronchiolitis focused on measuring Acute Bronchiolitis, Chest Physiotherapy, Forced Expiratory Techniques, Double Blind Trial, Children, Pediatric, RESPIRATORY SYNCYTIAL VIRUS

Eligibility Criteria

15 Days - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jean Verdier Hospital
  • Ambroise Paré Hospital
  • Antoine Béclère Hospital - Pediatric Department
  • Kremlin Bicetre Hospital
  • Trousseau Hospital
  • Necker - Enfants Malades Hospital
  • Robert Debré Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Chest Physiotherapy with Forced Expiratory Technique

Aspiration

Outcomes

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

Secondary Outcome Measures

Safety of the forced expiratory technique
Comparison of pulse oxymetry before/after chest physiotherapy
Quality of Life Scale

Full Information

First Posted
July 29, 2005
Last Updated
May 26, 2008
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association des Réseaux Bronchiolite
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1. Study Identification

Unique Protocol Identification Number
NCT00125450
Brief Title
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
Acronym
BRONKINOU
Official Title
Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Association des Réseaux Bronchiolite

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Bronchiolitis
Keywords
Acute Bronchiolitis, Chest Physiotherapy, Forced Expiratory Techniques, Double Blind Trial, Children, Pediatric, RESPIRATORY SYNCYTIAL VIRUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Chest Physiotherapy with Forced Expiratory Technique
Arm Title
B
Arm Type
Active Comparator
Arm Description
Aspiration
Intervention Type
Procedure
Intervention Name(s)
Chest Physiotherapy with Forced Expiratory Technique
Other Intervention Name(s)
A. Chest Physiotherapy with Forced Expiratory Technique
Intervention Description
Chest Physiotherapy with Forced Expiratory Technique
Intervention Type
Procedure
Intervention Name(s)
Nasopharyngeal Aspiration
Intervention Description
Nasopharyngeal Aspiration
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Safety of the forced expiratory technique
Time Frame
during hospitalisation
Title
Comparison of pulse oxymetry before/after chest physiotherapy
Time Frame
during hospitalisation
Title
Quality of Life Scale
Time Frame
on discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Days
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Gajdos, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe Labrune, MD - PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Jean Verdier Hospital
City
Bondy
ZIP/Postal Code
93140
Country
France
Facility Name
Ambroise Paré Hospital
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Antoine Béclère Hospital - Pediatric Department
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Kremlin Bicetre Hospital
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Trousseau Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Necker - Enfants Malades Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Robert Debré Hospital
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15846736
Citation
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. doi: 10.1002/14651858.CD004873.pub2.
Results Reference
background
PubMed Identifier
20927359
Citation
Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.
Results Reference
derived
Links:
URL
http://www.aphp.fr
Description
sponsor web site

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

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