BronchiolitisNCT04650230
HFNC Versus NCPAP/ NPPV in Infants With Severe Bronchiolitis
A study testing nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices in people with Bronchiolitis, run by Children's Hospital of Tunis.
Trial summary
The purpose of the study was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis 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?
- nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Mar 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
- Clinical diagnosis of bronchiolitis defined as the first viral episode of respiratory distress before 2 years of aging, presenting with rhinitis, tachypnea, cough, wheezing, prolonged expiratory time, crackles and use of accessory muscles, with or without fever, with or without infiltrate on the chest X ray
- bronchiolitis severity Wang modified score ≥ 10
Who cannot join
- recurrent wheezing
- heart disease
- chronic lung disease
- neuromuscular disease
- primary diagnosis was not bronchiolitis (pneumonia, pertussis)
- critically ill infants who had an immediate need of intubation
About this study
Official title: High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis
The purpose of the study was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis
Read the detailed description
The authors conducted a randomized controlled trial in the PICU of Children's hospital of Tunis. Participants aged from 7 days to 6 months, were eligible if all inclusion criteria were verified.
On admission, demographic and clinical data were collected. When a participant met the inclusion criteria, respiratory support was randomly allocated as high flow nasal cannula (HFNC) or nasal continuous positive airway pressure / nasal positive pressure ventilation (CPAP/NPPV).
Clinical parameters were monitored at treatment start and every 6 hours during the first 24 hours and then twice daily thereafter.
Participants in the HFNC group received heated and humidified gas flow with the Fisher \& Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%).
Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increased work of breathing.
If CPAP failed to improve clinical respiratory distress, infant was allocated to NPPV strategy. Clinicians were not be authorized to change from CPAP to HFNC but if HFNC failed, they had to change HFNC to CPAP/NPPV strategy ventilation before intubation.
Treatment failure criteria were urgent need to intubation or FiO2 superior to 60 % to maintain SpO2 ≥ 90% or increased work of breathing.
Sample size (134 per group) was calculated on the basis of Type I error equal to 0,05, on statistical power equal to 0.95 on failure rate among controls estimated at 30% and assuming a minimum difference of failure rate to declare the superiority of intervention equal to 20%. A dropout rate equal to 20% was used for this calculation.
Statistical Analysis Comparison of proportions was performed using Fisher exact test, and Student t test was used for comparison of means. For all analyses, significance level was defined as p < 0.05.
All statistical analyses were performed using Microsoft Excel 365.
- Conditions
- Bronchiolitis
- Being tested
- nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devicesDevice
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula (HFNC) | Active comparator | Participants in the HFNC group received heated and humidified gas flow with the Fisher \& Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%). Receives: Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices |
| nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) | Active comparator | Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increase of work of breath. Receives: Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with HFNC success
success was defined by no need of another respiratory support device
Measured: during hospitalization, approximatly 6 days
Number of participants with CPAP/NPPV success
success was defined by no need of another support device
Measured: during hospitalization, approximatly 6 days
Secondary outcomes (1)
rate of intubation
need of intubation
Measured: during hospitalization, approximatly 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study startDec 2013
- Primary completionMar 2017
- Study completionMar 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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Borgi, Children's Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650230
- Sponsor's protocol ID
- RPP1
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis
- ClinicalTrials.gov ID
- NCT04650230
- Acronym / sponsor ID
- RPP1
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Children's Hospital of TunisUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Dec 2020 (actual)
- 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 was to test the null hypothesis that there is no difference between nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory support mode for severe bronchiolitis
Detailed description
The authors conducted a randomized controlled trial in the PICU of Children's hospital of Tunis. Participants aged from 7 days to 6 months, were eligible if all inclusion criteria were verified.
On admission, demographic and clinical data were collected. When a participant met the inclusion criteria, respiratory support was randomly allocated as high flow nasal cannula (HFNC) or nasal continuous positive airway pressure / nasal positive pressure ventilation (CPAP/NPPV).
Clinical parameters were monitored at treatment start and every 6 hours during the first 24 hours and then twice daily thereafter.
Participants in the HFNC group received heated and humidified gas flow with the Fisher \& Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%).
Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increased work of breathing.
If CPAP failed to improve clinical respiratory distress, infant was allocated to NPPV strategy. Clinicians were not be authorized to change from CPAP to HFNC but if HFNC failed, they had to change HFNC to CPAP/NPPV strategy ventilation before intubation.
Treatment failure criteria were urgent need to intubation or FiO2 superior to 60 % to maintain SpO2 ≥ 90% or increased work of breathing.
Sample size (134 per group) was calculated on the basis of Type I error equal to 0,05, on statistical power equal to 0.95 on failure rate among controls estimated at 30% and assuming a minimum difference of failure rate to declare the superiority of intervention equal to 20%. A dropout rate equal to 20% was used for this calculation.
Statistical Analysis Comparison of proportions was performed using Fisher exact test, and Student t test was used for comparison of means. For all analyses, significance level was defined as p < 0.05.
All statistical analyses were performed using Microsoft Excel 365.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula (HFNC) | Active comparator | Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devicesParticipants in the HFNC group received heated and humidified gas flow with the Fisher \& Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for the size of cannula and a constant flow temperature of 37 °C.The flow rate will be progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent (%). |
| nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) | Active comparator | Device: nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devicesParticipants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours from the optimal PEEP when FiO2 was inferior to 30% and there is no increase of work of breath. |
Who may qualify
- Ages
- 7 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of bronchiolitis defined as the first viral episode of respiratory distress before 2 years of aging, presenting with rhinitis, tachypnea, cough, wheezing, prolonged expiratory time, crackles and use of accessory muscles, with or without fever, with or without infiltrate on the chest X ray
- bronchiolitis severity Wang modified score ≥ 10
Key exclusion criteria (6 listed)
- recurrent wheezing
- heart disease
- chronic lung disease
- neuromuscular disease
- primary diagnosis was not bronchiolitis (pneumonia, pertussis)
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 |
|---|---|---|
| nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices | Device | high flow nasal cannula (HFNC), nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) |
Primary outcome
Number of participants with HFNC success
Time frame: during hospitalization, approximatly 6 days
success was defined by no need of another respiratory support device
Number of participants with CPAP/NPPV success
Time frame: during hospitalization, approximatly 6 days
success was defined by no need of another support device
1 secondary outcome
rate of intubation
Time frame: during hospitalization, approximatly 6 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 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices in people with Bronchiolitis, run by Children's Hospital of Tunis.
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 6 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with HFNC success (time frame: during hospitalization, approximatly 6 days). The study lists 2 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.