ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02618213
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Signe Vahlkvist, Hospital of South West Denmark

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.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Bronchiolitis Device: Optiflow Junior Device: Continous Positive Airway Pressure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High Flow Oxygenation Therapy and CPAP in Children With Bronchiolitis.
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Arm Intervention/treatment
Active Comparator: Continous Positive Airway Pressure
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.
Device: Continous Positive Airway Pressure
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.
Other Name: CPAP

Active Comparator: High Flow Oxygenation Therapy
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
Device: Optiflow Junior
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
Other Names:
  • High Flow Oxygenation Therapy
  • HFOT




Primary Outcome Measures :
  1. respiration rate [ Time Frame: after 6 12 18 24 and 48 hour of intervention ]
    change in respiration rate ( RR) from preintervention value

  2. PCo2 [ Time Frame: after 6 12 24 and 48 hours of intervention ]
    Change in PCo2 (partial pressure of carbon dioxide)from pre intervention value

  3. Modified asthma score (MWAS) [ Time Frame: Once daily as long as intervention precedes ( 1-14 days) ]
    Change in MWAS from pre intervention value


Secondary Outcome Measures :
  1. treatment length [ Time Frame: from beginning of intervention to discontinuation (1-14 days) ]
    duration of need of intervention ( hours)

  2. Hspitalization [ Time Frame: from hospitalization to release (1-21 days) ]
    duration of hospitalisation ( days)

  3. Intervention failure. [ Time Frame: from beginning of intervention to discontinuation.(1-14 days) ]
    numbers of intervention failure defined as change of intervention or progression to need for intensive care/ mechanical ventilation.

  4. patient acceptance of intervention [ Time Frame: daily VAS score (0-5) from beginning of intervention to discontinuation (1-14 days) ]
    VAS score of tolerance with intervention. 0 = worst possible acceptance 5 = fully acceptance



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618213


Locations
Denmark
Hospital Lillebaelt
Kolding, Denmark, 6000
Signe Vahlkvist
Kolding, Denmark, 6000
Sponsors and Collaborators
Hospital of South West Denmark
Investigators
Principal Investigator: Signe VAhlkvist, MD PhD Pediatric Award, Hospital of South West Denmark

Responsible Party: Signe Vahlkvist, MD PhD, Hospital of South West Denmark
ClinicalTrials.gov Identifier: NCT02618213     History of Changes
Other Study ID Numbers: S-20150007
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Signe Vahlkvist, Hospital of South West Denmark:
Continuous Positive Airway Pressure
High Flow Oxygenation therapy
Bronchiolitis
Children

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections