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

NCT ID: NCT00125450

Last Updated: 2008-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Viral Bronchiolitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Chest Physiotherapy with Forced Expiratory Technique

Group Type EXPERIMENTAL

Chest Physiotherapy with Forced Expiratory Technique

Intervention Type PROCEDURE

Chest Physiotherapy with Forced Expiratory Technique

B

Aspiration

Group Type ACTIVE_COMPARATOR

Nasopharyngeal Aspiration

Intervention Type PROCEDURE

Nasopharyngeal Aspiration

Interventions

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Chest Physiotherapy with Forced Expiratory Technique

Chest Physiotherapy with Forced Expiratory Technique

Intervention Type PROCEDURE

Nasopharyngeal Aspiration

Nasopharyngeal Aspiration

Intervention Type PROCEDURE

Other Intervention Names

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A. Chest Physiotherapy with Forced Expiratory Technique

Eligibility Criteria

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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
Minimum Eligible Age

15 Days

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association des Réseaux Bronchiolite

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpemnt

Principal Investigators

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Vincent Gajdos, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Philippe Labrune, MD - PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Jean Verdier Hospital

Bondy, , France

Site Status

Ambroise Paré Hospital

Boulogne-Billancourt, , France

Site Status

Antoine Béclère Hospital - Pediatric Department

Clamart, , France

Site Status

Kremlin Bicetre Hospital

Le Kremlin-Bicêtre, , France

Site Status

Trousseau Hospital

Paris, , France

Site Status

Necker - Enfants Malades Hospital

Paris, , France

Site Status

Robert Debré Hospital

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 15846736 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37010196 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20927359 (View on PubMed)

Related Links

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http://www.aphp.fr

sponsor web site

Other Identifiers

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AOM 03123

Identifier Type: -

Identifier Source: secondary_id

DGS 2004/0276

Identifier Type: -

Identifier Source: secondary_id

P030421

Identifier Type: -

Identifier Source: org_study_id