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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT04650230
Study groupRoleWhat they receive
high flow nasal cannula (HFNC)Active comparatorParticipants 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 comparatorParticipants 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.

  1. Number of participants with HFNC success

    success was defined by no need of another respiratory support device

    Measured: during hospitalization, approximatly 6 days

  2. 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)
  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.

  1. First posted2 Dec 2020
  2. Study startDec 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

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)
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

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.

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