BronchiolitisTRAMONTANE2NCT02824744
Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants
A study testing treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) and treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) in people with Bronchiolitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants. Design: Prospective, controlled, randomized, multi-center. Read more about this study
- Who is it for?
- Ages 0 hours to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) and treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2016to Mar 2018
- 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 0 hours to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age < 6 months
- bronchiolitis
- mWCAS > or =3
- hospitalisation: PICU
- signed consent form by parents
Who cannot join
- Intubated patient
- Neurological or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants
The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.
Design: Prospective, controlled, randomized, multi-center.
Read more
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:HFNC "2l/min/kg" or HFNC "3l/min/kg" 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 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2
Statistic: Intention to treat Analysis.
Expected number of patients: 135 per arm: 270 children.
- Conditions
- Bronchiolitis
- Being tested
- treatment by 2l/min/kg in High Flow Nasal cannula (HFNC), treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)
- Keywords
- Bronchiolitis, High flow nasal canula
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)Device
treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)Device
| Study group | Role | What they receive |
|---|---|---|
| treatment by 2l/min/kg in HFNC | Active comparator | treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) Receives: Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) |
| treatment by 3l/min/kg in HFNC | Experimental | treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) Receives: Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of failure in both arms
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.
Measured: up to 24 hours
Secondary outcomes (4)
assessment of heart rate in both arm
Measured: up to 24 hours
Assessment of the discomfort in both arms with the score of EDIN
Measured: up to 24 hours
assessment of the fraction of inspired oxygen (FiO2) in both arms
FiO2 required to achieve an oxygen saturation between 94 and 97%
Measured: up to 24 hours
number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start2 Nov 2016
- Primary completion17 Mar 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824744
- Sponsor's protocol ID
- 9719
- Acronym
- TRAMONTANE2
- Status last verified
- Jul 2016
- First submitted
- 27 Jun 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All data will be centralized at the sponsor office for the final analysis
Publications
Milesi C, Nogue E, Baleine J, Moulis L, Pouyau R, Gavotto A, Brossier D, Mortamet G, Cambonie G; GFRUP Respiratory Study Group. ROX (Respiratory rate-OXygenation) index to predict early response to high-flow nasal cannula therapy in infants with viral bronchiolitis. Pediatr Pulmonol. 2024 Apr;59(4):982-990. doi: 10.1002/ppul.26860. Epub 2024 Jan 10.
PubMed 38197495Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.
PubMed 30343318
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants
- ClinicalTrials.gov ID
- NCT02824744
- Acronym / sponsor ID
- TRAMONTANE2 / 9719
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, High flow nasal canula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 7 Jul 2016 (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 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.
Design: 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:HFNC "2l/min/kg" or HFNC "3l/min/kg" 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 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2
Statistic: Intention to treat Analysis.
Expected number of patients: 135 per arm: 270 children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment by 2l/min/kg in HFNC | Active comparator | Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) |
| treatment by 3l/min/kg in HFNC | Experimental | Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old) |
Who may qualify
- Ages
- 0 hours to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age < 6 months
- bronchiolitis
- mWCAS > or =3
- hospitalisation: PICU
- signed consent form by 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 |
|---|---|---|
| treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) | Device | treatment by 2l/min/kg in HFNC |
| treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) | Device | treatment by 3l/min/kg in HFNC |
Primary outcome
Proportion of failure in both arms
Time frame: up to 24 hours
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.
4 secondary outcomes
assessment of heart rate in both arm
Time frame: up to 24 hours
Assessment of the discomfort in both arms with the score of EDIN
Time frame: up to 24 hours
assessment of the fraction of inspired oxygen (FiO2) in both arms
Time frame: up to 24 hours
number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)
Time frame: up to 24 hours
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 15 Jun 2026.
- Results publication: PubMed 38197495Milesi C, Nogue E, Baleine J, Moulis L, Pouyau R, Gavotto A, Brossier D, Mortamet G, Cambonie G; GFRUP Respiratory Study Group. ROX (Respiratory rate-OXygenation) index to predict early response to high-flow nasal cannula therapy in infants with viral bronchiolitis. Pediatr Pulmonol. 2024 Apr;59(4):982-990. doi: 10.1002/ppul.26860. Epub 2024 Jan 10.
- Results publication: PubMed 30343318Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.
- Individual participant dataSharing planned: Yes. All data will be centralized at the sponsor office for the final analysis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) and treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) 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: finished, as of the sponsor's last update on 15 Jun 2026. 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?
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?
Proportion of failure in both arms (time frame: up to 24 hours). 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 NCT02824744, which also lists 2 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 15 Jun 2026.