BronchiolitisNCT02737280
High Flow Nasal Cannula Use in Infants With Bronchiolitis
A study testing Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy and MedKit Finland - Usual oxygen therapy in people with Bronchiolitis, run by University of Oulu at 4 sites in Finland.
Trial summary
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy and MedKit Finland - Usual oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesFinland
- Study dates
- Mar 2016to Sep 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to pediatric ward due to a presumed viral bronchiolitis
- Need of oxygen therapy (oxygen saturation < 92%)
Who cannot join
- Pertussis
- Needs intubation or CPAP on admission
- Severe congenital heart defect
- Down's syndrome
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Central Hospital Jyväskylä
Jyväskylä
Oulu Unversity Hospital
Oulu
Seinäjoki Central Hospital
Seinäjoki
Tampere University Hospital
Tampere
About this study
Official title: High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Read the detailed description
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
- Conditions
- Bronchiolitis
- Being tested
- Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy, MedKit Finland - Usual oxygen therapy
- Keywords
- infant, high flow nasal cannulae, 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.
Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapyDevice
High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device
MedKit Finland - Usual oxygen therapyDevice
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
| Study group | Role | What they receive |
|---|---|---|
| Usual oxygen therapy | Active comparator | Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min Receives: Device: MedKit Finland - Usual oxygen therapy |
| High flow oxygen therapy | Experimental | High flow nasal cannula oxygen therapy with Airvo (TM, Fisher \& Paykel Healthcare) device Receives: Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment failure
Treatment failure = need for change of respiratory support method
Measured: 720 hours
Secondary outcomes (5)
Respiratory rate measured by the study physician/nurse
Measured: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Oxygen saturation (%)
Measured: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from randomisation to end of oxygen therapy
Measured: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from hospital admission to discharge (hours)
The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups.
Measured: 720 hours
Number of participants needing admission to intensive care unit (ICU)
The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups.
Measured: 720 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2018
- Study completionSep 2018
Why it stopped: Slow recruitment
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.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marjo Renko, University of Oulu
- Investigators
- Marjo Renko, MD, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737280
- Sponsor's protocol ID
- EETTMK2015
- Status last verified
- Dec 2018
- First submitted
- 26 Feb 2016
- Last updated
- 19 Dec 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 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02737280
- Acronym / sponsor ID
- EETTMK2015
- Conditions
- Bronchiolitis
- Keywords
- infant, high flow nasal cannulae, oxygen therapy, bronchiolitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 13 Apr 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.
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Detailed description
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual oxygen therapy | Active comparator | Device: MedKit Finland - Usual oxygen therapyOxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min |
| High flow oxygen therapy | Experimental | Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapyHigh flow nasal cannula oxygen therapy with Airvo (TM, Fisher \& Paykel Healthcare) device |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Admission to pediatric ward due to a presumed viral bronchiolitis
- Need of oxygen therapy (oxygen saturation < 92%)
Key exclusion criteria (4 listed)
- Pertussis
- Needs intubation or CPAP on admission
- Severe congenital heart defect
- Down's syndrome
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 |
|---|---|---|
| Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapyHigh flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device | Device | High flow oxygen therapy |
| MedKit Finland - Usual oxygen therapyOxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min | Device | Usual oxygen therapy |
Primary outcome
Number of patients with treatment failure
Time frame: 720 hours
Treatment failure = need for change of respiratory support method
5 secondary outcomes
Respiratory rate measured by the study physician/nurse
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Oxygen saturation (%)
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from randomisation to end of oxygen therapy
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from hospital admission to discharge (hours)
Time frame: 720 hours
Number of participants needing admission to intensive care unit (ICU)
Time frame: 720 hours
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Marjo Renko, MD, PhD principal investigator
University of Oulu
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy and MedKit Finland - Usual oxygen therapy in people with Bronchiolitis, run by University of Oulu at 4 sites in Finland.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Number of patients with treatment failure (time frame: 720 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 19 Dec 2018.