Respiratory Syncytial Virus BronchiolitisNCT02618213
Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
A study testing Optiflow Junior and Continous Positive Airway Pressure in people with Respiratory Syncytial Virus Bronchiolitis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 2 sites in Denmark.
Trial summary
Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Respiratory Syncytial Virus Bronchiolitis
- What is being tested?
- Optiflow Junior and Continous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Dec 2015to 1 May 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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)
Who cannot join
- severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.
Trial locations and contacts
2 sites in 1 country.
About this study
Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.
Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.
- Being tested
- Optiflow Junior, Continous Positive Airway Pressure
- Keywords
- Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow JuniorDevice
Also called High Flow Oxygenation Therapy, HFOT
Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system
Continous Positive Airway PressureDevice
Also called CPAP
Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system.
| Study group | Role | What they receive |
|---|---|---|
| Continous Positive Airway Pressure | Active comparator | CPAP is administered through a binasal tube fitted with a Benveniste gas jet administered with humified airflow. Start flow is 12-14 l/min and can be changed to maximum 15 or minimum 12 l/min. Oxygen can be supplied as needed to keep SpO2 (peripheral capillary Oxygen saturation) within acceptable limits. Receives: Device: Continous Positive Airway Pressure |
| High Flow Oxygenation Therapy | Active comparator | HFOT is administered by optiflow Junior ( Fisher\&Paykal Healthcare® Auckland, New Zealand) Start flow 12-14 l/min. Oxygen can be supplied as needed to keep Sp02 within acceptable limits Receives: Device: Optiflow Junior |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiration rate
change in respiration rate ( RR) from preintervention value
Measured: after 6 12 18 24 and 48 hour of intervention
PCo2
Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
Measured: after 6 12 24 and 48 hours of intervention
Modified asthma score (MWAS)
Change in MWAS from pre intervention value
Measured: Once daily as long as intervention precedes ( 1-14 days)
Secondary outcomes (4)
treatment length
duration of need of intervention ( hours)
Measured: from beginning of intervention to discontinuation (1-14 days)
Hspitalization
duration of hospitalisation ( days)
Measured: from hospitalization to release (1-21 days)
Intervention failure.
numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.
Measured: from beginning of intervention to discontinuation.(1-14 days)
patient acceptance of intervention
VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance
Measured: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start1 Dec 2015
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Voss Vahlkvist, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Signe VAhlkvist, MD PhD, Principal investigator, Pediatric Award, Hospital of South West Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618213
- Sponsor's protocol ID
- S-20150007
- Status last verified
- Oct 2022
- First submitted
- 25 Nov 2015
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
- ClinicalTrials.gov ID
- NCT02618213
- Acronym / sponsor ID
- S-20150007
- Keywords
- Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 1 Dec 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.
Bronchiolitis in infants and young children often requires respiraty support. In Denmark Continous Positive Airway Pressure ( CPAP) are routinely used in children with moderate-severe bronchiolitis. The aim of the study is to compare CPAP and High Flow Oxygenation Therapy (HFOT) as tools of respiratory support in infants and young children with bronchiolitis.
Infants and young children with moderate-severe bronchiolitis and are randomized to either CPAP or HFOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous Positive Airway Pressure | Active comparator | Device: Continous Positive Airway PressureCPAP is administered through a binasal tube fitted with a Benveniste gas jet administered with humified airflow. Start flow is 12-14 l/min and can be changed to maximum 15 or minimum 12 l/min. Oxygen can be supplied as needed to keep SpO2 (peripheral capillary Oxygen saturation) within acceptable limits. |
| High Flow Oxygenation Therapy | Active comparator | Device: Optiflow JuniorHFOT is administered by optiflow Junior ( Fisher\&Paykal Healthcare® Auckland, New Zealand) Start flow 12-14 l/min. Oxygen can be supplied as needed to keep Sp02 within acceptable limits |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)
Key exclusion criteria (1 listed)
- severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.
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 |
|---|---|---|
| Optiflow JuniorAlso: High Flow Oxygenation Therapy, HFOTHumified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system | Device | High Flow Oxygenation Therapy |
| Continous Positive Airway PressureAlso: CPAPHumified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system. | Device | Continous Positive Airway Pressure |
Primary outcome
respiration rate
Time frame: after 6 12 18 24 and 48 hour of intervention
change in respiration rate ( RR) from preintervention value
PCo2
Time frame: after 6 12 24 and 48 hours of intervention
Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
Modified asthma score (MWAS)
Time frame: Once daily as long as intervention precedes ( 1-14 days)
Change in MWAS from pre intervention value
4 secondary outcomes
treatment length
Time frame: from beginning of intervention to discontinuation (1-14 days)
Hspitalization
Time frame: from hospitalization to release (1-21 days)
Intervention failure.
Time frame: from beginning of intervention to discontinuation.(1-14 days)
patient acceptance of intervention
Time frame: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 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 25 Oct 2022.
Related trials for Respiratory Syncytial Virus Bronchiolitis
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Not yet recruitingObservational study
Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Acute Bronchiolitis, Viral Bronchiolitis
Active, not recruitingObservational study
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Active, not recruitingObservational study
Transplacental Transmission of RSV (TTRSV)
SARS CoV 2 Infection, Respiratory Syncytial Virus (RSV)
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.
Signe VAhlkvist, MD PhD principal investigator
Pediatric Award, Hospital of South West Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow Junior and Continous Positive Airway Pressure in people with Respiratory Syncytial Virus Bronchiolitis, run by Esbjerg Hospital - University Hospital of Southern Denmark at 2 sites in Denmark.
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 1 inclusion and 1 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 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
respiration rate (time frame: after 6 12 18 24 and 48 hour of intervention). The study lists 3 primary outcomes in all. 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 25 Oct 2022.