BronchiolitisTRAMONTANENCT02457013
Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
A study testing HFNC and nCPAP in people with Bronchiolitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants. 2. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- HFNC and nCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Nov 2016
- 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 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age<6months
- bronchiolitis
- mWCAS > or=3
- hospitalisation in pediatric intensive care unit
- signed consent form (2 parents)
Who cannot join
- Intubated patient
- Neurological or cardiac disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Montpellier
Montpellier, 34395
About this study
- The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
- Design: non-inferiority study, prospective, controlled, randomized, multi-center.
- Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
- Conditions of measurements: Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea. Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2
- Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
- Study Schedule: October 2014-April 2016
- Conditions
- Bronchiolitis
- Being tested
- HFNC, nCPAP
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCDevice
Hygh flow nasal canula HFNC
nCPAPDevice
nasal nCPAP
| Study group | Role | What they receive |
|---|---|---|
| HFNC treatment | Experimental | HFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours) Receives: Device: HFNC |
| nCPAP treatment | Active comparator | nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours) Receives: Device: nCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of failure
Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.
Measured: 24 hours
Secondary outcomes (12)
number of participants with an aggravation of the clinical score for respiratory distress arms
comparison of the clinical score for respiratory distress (mWCAS) in both arms
Measured: 1hour
number of participants with an aggravation of the clinical score for respiratory distress arms
comparison of the clinical score for respiratory distress (mWCAS) in both arms
Measured: 12hours
number of participants with an increase of the clinical score for respiratory distress arms
Assessment of Report Sp02/Fi02in both arms
Measured: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Measured: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Measured: 12 hours
Comparison of the Report Sp02/Fi02 in both arms
Assessment of Report Sp02/Fi02in both arms
Measured: 24 hours
number of participants with skin lesions in both arms
number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)
Measured: 1 hour
number of participants with skin lesions in both arms
number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)
Measured: 12 hours
number of participants with skin lesions in both arms
number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)
Measured: 24 hours
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Measured: 1 hour
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Measured: 12 hours
number of participants with Discomfort in both arms
Assessment of the discomfort in both arms with the score of EDIN
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startOct 2014
- Primary completionApr 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457013
- Sponsor's protocol ID
- 9433
- Acronym
- TRAMONTANE
- Status last verified
- May 2015
- First submitted
- 27 Jan 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants
- ClinicalTrials.gov ID
- NCT02457013
- Acronym / sponsor ID
- TRAMONTANE / 9433
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 29 May 2015 (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 the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
- Design: non-inferiority study, prospective, controlled, randomized, multi-center.
- Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
- Conditions of measurements: Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea. Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2
- Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
- Study Schedule: October 2014-April 2016
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC treatment | Experimental | Device: HFNCHFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours) |
| nCPAP treatment | Active comparator | Device: nCPAPnCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours) |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age<6months
- bronchiolitis
- mWCAS > or=3
- hospitalisation in pediatric intensive care unit
- signed consent form (2 parents)
Key exclusion criteria (2 listed)
- Intubated patient
- Neurological or cardiac disease
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 |
|---|---|---|
| HFNCHygh flow nasal canula HFNC | Device | HFNC treatment |
| nCPAPnasal nCPAP | Device | nCPAP treatment |
Primary outcome
Proportion of failure
Time frame: 24 hours
Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.
12 secondary outcomes
number of participants with an aggravation of the clinical score for respiratory distress arms
Time frame: 1hour
number of participants with an aggravation of the clinical score for respiratory distress arms
Time frame: 12hours
number of participants with an increase of the clinical score for respiratory distress arms
Time frame: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Time frame: 1 hour
Comparison of the Report Sp02/Fi02 in both arms
Time frame: 12 hours
Comparison of the Report Sp02/Fi02 in both arms
Time frame: 24 hours
number of participants with skin lesions in both arms
Time frame: 1 hour
number of participants with skin lesions in both arms
Time frame: 12 hours
number of participants with skin lesions in both arms
Time frame: 24 hours
number of participants with Discomfort in both arms
Time frame: 1 hour
number of participants with Discomfort in both arms
Time frame: 12 hours
number of participants with Discomfort in both arms
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and nCPAP in people with Bronchiolitis, run by University Hospital, Montpellier at 1 site 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe MILESI, Doctor (0033467336609, c-milesi@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of failure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.