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High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices
Sponsored by
Children's Hospital of Tunis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis

Eligibility Criteria

7 Days - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    high flow nasal cannula (HFNC)

    nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)

    Arm Description

    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 increase of work of breath.

    Outcomes

    Primary Outcome Measures

    escalation of care
    need of another respiratory support device

    Secondary Outcome Measures

    rate of intubation
    need of intubation

    Full Information

    First Posted
    November 25, 2020
    Last Updated
    November 25, 2020
    Sponsor
    Children's Hospital of Tunis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04650230
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Children's Hospital of Tunis

    4. Oversight

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    268 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high flow nasal cannula (HFNC)
    Arm Type
    Active Comparator
    Arm Description
    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 (%).
    Arm Title
    nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices
    Primary Outcome Measure Information:
    Title
    escalation of care
    Description
    need of another respiratory support device
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    rate of intubation
    Description
    need of intubation
    Time Frame
    48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Days
    Maximum Age & Unit of Time
    6 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis

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