BronchiolitisBRONCHOPTINCT02856165
High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis
A study testing High-flow nasal canula oxygen therapy and Low-flow oxygen therapy with standard nasal canula in people with Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis. However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal… Read more about this study
- Who is it for?
- Ages 7 days to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- High-flow nasal canula oxygen therapy and Low-flow oxygen therapy with standard nasal canula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2016to 23 Nov 2017
- 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 7 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
- aged 7 days- 6 months
- transcutaneous SpO2 in room air < 95%
- modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
- agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
- affiliation to social security (beneficiary or entitled), except beneficiary of State medical help
Who cannot join
- Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
- Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
- Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial
Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis.
However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.
Read the detailed description
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- High-flow nasal canula oxygen therapy, Low-flow oxygen therapy with standard nasal canula
- Keywords
- infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal canula oxygen therapyDevice
Also called Optiflow
High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F\&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 > 94%.
Low-flow oxygen therapy with standard nasal canulaDevice
Also called Low-flow oxygen therapy
flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal canula oxygen therapy | Experimental | High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher\&Paykel (F\&P), NZ) Receives: Device: High-flow nasal canula oxygen therapy |
| Low-flow oxygen therapy | Active comparator | Low-flow oxygen therapy with standard nasal canula Receives: Device: Low-flow oxygen therapy with standard nasal canula |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
Treatment failure is defined if one or more following criteria are met: refractory apnea (> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds >2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or > 5 , PaCO2 (H6 ) increased compared to admission and > 60-70 mmHg.
Measured: Up to an average of 7 days
Secondary outcomes (5)
Transfer to pediatrics intensive care unit (PICU)
Numbers of infants transferred to PICU in each arm
Measured: at the end of the follow up (an average of 7 days)
Length of stay in paediatric general ward unit
number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
Measured: at the end of the follow up (an average of 7 days)
Oxgen-support free days
number of oxygen support free days
Measured: at the end of the follow up (an average of 7 days)
Artificial nutritional-support free days
number of artificial nutritional-support free days (enteral feeding or intravenous line)
Measured: at the end of the follow up (an average of 7 days)
Assessment of short term respiratory status
Sequential assessment of short term (H1, 6, 12, 24) respiratory status including respiratory rate, heart-rate, SpO2, m-WCAS score, transcutaneous carbon dioxide partial pressure (tcPaCO2).
Measured: at the end of the follow up (an average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start28 Oct 2016
- Primary completion15 Nov 2017
- Study completion23 Nov 2017
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DURAND, MD, Principal investigator, AP-HP, Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856165
- Sponsor's protocol ID
- P150931
- Acronym
- BRONCHOPTI
- Status last verified
- Apr 2018
- First submitted
- 19 Jul 2016
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02856165
- Acronym / sponsor ID
- BRONCHOPTI / P150931
- Conditions
- Bronchiolitis
- Keywords
- infant, oxygen therapy, High flow nasal canula oxygen therapy, Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 4 Aug 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.
Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis.
However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.
Detailed description
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal canula oxygen therapy | Experimental | Device: High-flow nasal canula oxygen therapyHigh-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher\&Paykel (F\&P), NZ) |
| Low-flow oxygen therapy | Active comparator | Device: Low-flow oxygen therapy with standard nasal canulaLow-flow oxygen therapy with standard nasal canula |
Who may qualify
- Ages
- 7 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
- aged 7 days- 6 months
- transcutaneous SpO2 in room air < 95%
- modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
- agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
Key exclusion criteria (3 listed)
- Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
- Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
- Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy
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 |
|---|---|---|
| High-flow nasal canula oxygen therapyAlso: OptiflowHigh-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F\&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 > 94%. | Device | High-flow nasal canula oxygen therapy |
| Low-flow oxygen therapy with standard nasal canulaAlso: Low-flow oxygen therapyflow adjusted to SpO2 > 94% (up to a maximum of 2l/min). | Device | Low-flow oxygen therapy |
Primary outcome
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
Time frame: Up to an average of 7 days
Treatment failure is defined if one or more following criteria are met: refractory apnea (> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds >2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or > 5 , PaCO2 (H6 ) increased compared to admission and > 60-70 mmHg.
5 secondary outcomes
Transfer to pediatrics intensive care unit (PICU)
Time frame: at the end of the follow up (an average of 7 days)
Length of stay in paediatric general ward unit
Time frame: at the end of the follow up (an average of 7 days)
Oxgen-support free days
Time frame: at the end of the follow up (an average of 7 days)
Artificial nutritional-support free days
Time frame: at the end of the follow up (an average of 7 days)
Assessment of short term respiratory status
Time frame: at the end of the follow up (an average of 7 days)
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 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Philippe DURAND, MD principal investigator
AP-HP, Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal canula oxygen therapy and Low-flow oxygen therapy with standard nasal canula in people with Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 3 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 30 Apr 2018. 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?
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days (time frame: Up to an average of 7 days). 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 30 Apr 2018.