NCT00125450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

May 28, 2008

Status Verified

October 1, 2006

Enrollment Period

3.4 years

First QC Date

July 29, 2005

Last Update Submit

May 26, 2008

Conditions

Viral Bronchiolitis

Keywords

Acute BronchiolitisChest PhysiotherapyForced Expiratory TechniquesDouble Blind TrialChildrenPediatricRESPIRATORY SYNCYTIAL VIRUS

Outcome Measures

Primary Outcomes (1)

  • 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

    obtention

Secondary Outcomes (3)

  • Safety of the forced expiratory technique

    during hospitalisation

  • Comparison of pulse oxymetry before/after chest physiotherapy

    during hospitalisation

  • Quality of Life Scale

    on discharge

Study Arms (2)

A

EXPERIMENTAL

Chest Physiotherapy with Forced Expiratory Technique

Procedure: Chest Physiotherapy with Forced Expiratory Technique

B

ACTIVE COMPARATOR

Aspiration

Procedure: Nasopharyngeal Aspiration

Interventions

Chest Physiotherapy with Forced Expiratory TechniquePROCEDURE

Chest Physiotherapy with Forced Expiratory Technique

Also known as: A. Chest Physiotherapy with Forced Expiratory Technique
A
Nasopharyngeal AspirationPROCEDURE

Nasopharyngeal Aspiration

B

Eligibility Criteria

Age15 Days - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Prematurity (gestational age \< 32 weeks)
  • Brondysplasia
  • Chronic lung disease or congenital heart disease
  • Respiratory distress necessitating admission in the Pediatric Intensive Care Unit (PICU)
  • or more chest physiotherapy procedures since hospitalisation
  • Parental refusal
  • Any chest physiotherapy contra-indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Jean Verdier Hospital

Bondy, 93140, France

Location

Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

Location

Antoine Béclère Hospital - Pediatric Department

Clamart, 92140, France

Location

Kremlin Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Trousseau Hospital

Paris, 75012, France

Location

Necker - Enfants Malades Hospital

Paris, 75015, France

Location

Robert Debré Hospital

Paris, 75019, France

Location

Related Publications (3)

  • 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.

    PMID: 15846736BACKGROUND

  • Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.

    PMID: 37010196DERIVED

  • 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.

    PMID: 20927359DERIVED

Related Links

MeSH Terms

Conditions

Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Vincent Gajdos, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Philippe Labrune, MD - PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

September 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

May 28, 2008

Record last verified: 2006-10

Locations

FR(7)