Clinical trial NCT00125450: Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
Official title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Bronchiolitis
Keywords: Acute Bronchiolitis
Chest Physiotherapy
Forced Expiratory Techniques
Double Blind Trial
Children
Pediatric
RESPIRATORY SYNCYTIAL VIRUS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Association des Réseaux Bronchiolite
First posted: 2005-08-01
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: obtention
Secondary outcomes:
measure: Safety of the forced expiratory technique
timeFrame: during hospitalisation
measure: Comparison of pulse oxymetry before/after chest physiotherapy
timeFrame: during hospitalisation
measure: Quality of Life Scale
timeFrame: on discharge
Other outcomes:
Locations:
city: Bondy
country: France
facility: Jean Verdier Hospital
city: Boulogne Billancourt
country: France
facility: Ambroise Paré Hospital
city: Clamart
country: France
facility: Antoine Béclère Hospital - Pediatric Department
city: Le Kremlin Bicetre
country: France
facility: Kremlin Bicetre Hospital
city: Paris
country: France
facility: Trousseau Hospital
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Vincent Gajdos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Labrune, MD - PhD
role: STUDY_DIRECTOR
References:
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.
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.