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CompletedNCT00125450BRONKINOUUpdated May 28, 2008

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

An interventional study of Chest Physiotherapy with Forced Expiratory Technique and Nasopharyngeal Aspiration in Viral Bronchiolitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 7 sites in France. Open to participants aged 15 Days to 24 Months. Per ClinicalTrials.gov, last updated 2008-05-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
15 Days to 24 Months
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Viral Bronchiolitis

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Keywords

  • Acute Bronchiolitis
  • Chest Physiotherapy
  • Forced Expiratory Techniques
  • Double Blind Trial
  • Children
  • Pediatric
  • RESPIRATORY SYNCYTIAL VIRUS
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In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

This study's enrollment of 500 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.

Browse Bronchiolitis, Viral studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Days to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    A

    Chest Physiotherapy with Forced Expiratory Technique

    Procedure: Chest Physiotherapy with Forced Expiratory Technique

  • Active comparator
    B

    Aspiration

    Procedure: Nasopharyngeal Aspiration

Interventions

  • ProcedureChest Physiotherapy with Forced Expiratory Technique

    Chest Physiotherapy with Forced Expiratory Technique

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

  • ProcedureNasopharyngeal Aspiration

    Nasopharyngeal Aspiration

06

What researchers measure

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

    Time frame: obtention

Secondary outcomes

  1. Safety of the forced expiratory technique

    Time frame: during hospitalisation

  2. Comparison of pulse oxymetry before/after chest physiotherapy

    Time frame: during hospitalisation

  3. Quality of Life Scale

    Time frame: on discharge

07

Study locations

7 sites
  • Jean Verdier Hospital
    Bondy, 93140, France
  • Ambroise Paré Hospital
    Boulogne Billancourt, 92100, France
  • Antoine Béclère Hospital - Pediatric Department
    Clamart, 92140, France
  • Kremlin Bicetre Hospital
    Le Kremlin Bicetre, 94270, France
  • Trousseau Hospital
    Paris, 75012, France
  • Necker - Enfants Malades Hospital
    Paris, 75015, France
  • Robert Debré Hospital
    Paris, 75019, France
08

References and documents

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. doi: 10.1002/14651858.CD004873.pub2. PubMed 15846736 ↗
  • 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. PubMed 20927359 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00125450
Collaborators
Association des Réseaux Bronchiolite
First posted
Aug 1, 2005
Start date
Sep 2004
Primary completion
Feb 2008
Completion
Feb 2008
Last update
May 28, 2008

Study contacts

Vincent Gajdos, MD
principal investigator · Assistance Publique - Hôpitaux de Paris
Philippe Labrune, MD - PhD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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