search
Back to results

Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

Primary Purpose

Respiratory Syncytial Virus Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Optiflow Junior
Continous Positive Airway Pressure
Sponsored by
Hospital of South West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Bronchiolitis focused on measuring Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children

Eligibility Criteria

1 Day - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision)

Exclusion Criteria:

  • severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.

Sites / Locations

  • Hospital Lillebaelt
  • Signe Vahlkvist

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continous Positive Airway Pressure

High Flow Oxygenation Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

respiration rate
change in respiration rate ( RR) from preintervention value
PCo2
Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
Modified asthma score (MWAS)
Change in MWAS from pre intervention value

Secondary Outcome Measures

treatment length
duration of need of intervention ( hours)
Hspitalization
duration of hospitalisation ( days)
Intervention failure.
numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.
patient acceptance of intervention
VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance

Full Information

First Posted
November 25, 2015
Last Updated
October 24, 2022
Sponsor
Hospital of South West Jutland
search

1. Study Identification

Unique Protocol Identification Number
NCT02618213
Brief Title
Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Official Title
Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital of South West Jutland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Bronchiolitis
Keywords
Continuous Positive Airway Pressure, High Flow Oxygenation therapy, Bronchiolitis, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continous Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High Flow Oxygenation Therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optiflow Junior
Other Intervention Name(s)
High Flow Oxygenation Therapy, HFOT
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Continous Positive Airway Pressure
Other Intervention Name(s)
CPAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
respiration rate
Description
change in respiration rate ( RR) from preintervention value
Time Frame
after 6 12 18 24 and 48 hour of intervention
Title
PCo2
Description
Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value
Time Frame
after 6 12 24 and 48 hours of intervention
Title
Modified asthma score (MWAS)
Description
Change in MWAS from pre intervention value
Time Frame
Once daily as long as intervention precedes ( 1-14 days)
Secondary Outcome Measure Information:
Title
treatment length
Description
duration of need of intervention ( hours)
Time Frame
from beginning of intervention to discontinuation (1-14 days)
Title
Hspitalization
Description
duration of hospitalisation ( days)
Time Frame
from hospitalization to release (1-21 days)
Title
Intervention failure.
Description
numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.
Time Frame
from beginning of intervention to discontinuation.(1-14 days)
Title
patient acceptance of intervention
Description
VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance
Time Frame
daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infants and children with moderate respiratoric syncytial virus bronchiolitis or other viral bronchiolitis and need of respiratory support. ( clinical decision) Exclusion Criteria: severe bronchiolitis with P C02 > 9, decreased consciusness and risk for early progression to intensive therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe VAhlkvist, MD PhD
Organizational Affiliation
Pediatric Award, Hospital of South West Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Lillebaelt
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Signe Vahlkvist
City
Kolding
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.

We'll reach out to this number within 24 hrs