Viral BronchiolitisBRONKINOUNCT00125450
Evaluation of Chest Physiotherapy for Acute Bronchiolitis in Toddlers (BRONKINOU)
A study testing Chest Physiotherapy with Forced Expiratory Technique and Nasopharyngeal Aspiration in people with Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 15 days to 24 months
- Conditions the study is for
- Viral Bronchiolitis
- What is being tested?
- Chest Physiotherapy with Forced Expiratory Technique and Nasopharyngeal Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 7 sitesFrance
- Study dates
- Sep 2004to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 days to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Jean Verdier Hospital
Bondy, 93140
Ambroise Paré Hospital
Boulogne-Billancourt, 92100
Antoine Béclère Hospital - Pediatric Department
Clamart, 92140
Kremlin Bicetre Hospital
Le Kremlin-Bicêtre, 94270
Trousseau Hospital
Paris, 75012
Necker - Enfants Malades Hospital
Paris, 75015
Robert Debré Hospital
Paris, 75019
About this study
Official title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
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.
- Conditions
- Viral Bronchiolitis
- Being tested
- Chest Physiotherapy with Forced Expiratory Technique, Nasopharyngeal Aspiration
- Keywords
- Acute Bronchiolitis, Chest Physiotherapy, Forced Expiratory Techniques, Double Blind Trial, Children, Pediatric, RESPIRATORY SYNCYTIAL VIRUS
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Physiotherapy with Forced Expiratory TechniqueProcedure or surgery
Also called A. Chest Physiotherapy with Forced Expiratory Technique
Chest Physiotherapy with Forced Expiratory Technique
Nasopharyngeal AspirationProcedure or surgery
Nasopharyngeal Aspiration
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Chest Physiotherapy with Forced Expiratory Technique Receives: Procedure: Chest Physiotherapy with Forced Expiratory Technique |
| B | Active comparator | Aspiration Receives: Procedure: Nasopharyngeal Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: obtention
Secondary outcomes (3)
Safety of the forced expiratory technique
Measured: during hospitalisation
Comparison of pulse oxymetry before/after chest physiotherapy
Measured: during hospitalisation
Quality of Life Scale
Measured: on discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Viral BronchiolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association des Réseaux Bronchiolite
- Investigators
- Vincent Gajdos, MD, Principal investigator, Assistance Publique - Hôpitaux de ParisPhilippe Labrune, MD - PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125450
- Sponsor's protocol ID
- P030421
- Other IDs
- AOM 03123, DGS 2004/0276
- Acronym
- BRONKINOU
- Status last verified
- Oct 2006
- First submitted
- 29 Jul 2005
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 15846736Roque-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.
PubMed 37010196Gajdos 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
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers
- ClinicalTrials.gov ID
- NCT00125450
- Acronym / sponsor ID
- BRONKINOU / P030421
- Conditions
- Viral Bronchiolitis
- Keywords
- Acute Bronchiolitis, Chest Physiotherapy, Forced Expiratory Techniques, Double Blind Trial, Children, Pediatric, RESPIRATORY SYNCYTIAL VIRUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association des Réseaux Bronchiolite
- Study start
- Sep 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Chest Physiotherapy with Forced Expiratory TechniqueChest Physiotherapy with Forced Expiratory Technique |
| B | Active comparator | Procedure: Nasopharyngeal AspirationAspiration |
Who may qualify
- Ages
- 15 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest Physiotherapy with Forced Expiratory TechniqueAlso: A. Chest Physiotherapy with Forced Expiratory TechniqueChest Physiotherapy with Forced Expiratory Technique | Procedure or surgery | A |
| Nasopharyngeal AspirationNasopharyngeal Aspiration | Procedure or surgery | B |
Primary outcome
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
3 secondary outcomes
Safety of the forced expiratory technique
Time frame: during hospitalisation
Comparison of pulse oxymetry before/after chest physiotherapy
Time frame: during hospitalisation
Quality of Life Scale
Time frame: on discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Background: PubMed 15846736Perrotta 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.
- Derived from this study: PubMed 37010196Roque-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.
- Derived from this study: PubMed 20927359Gajdos 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.
- sponsor web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gajdos, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Philippe Labrune, MD - PhD study director
Assistance Publique - Hôpitaux de Paris
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Physiotherapy with Forced Expiratory Technique and Nasopharyngeal Aspiration in people with Viral Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: obtention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.