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

This study is currently recruiting participants.
Verified August 2017 by Signe Vahlkvist, Hospital of South West Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT02618213
First Posted: December 1, 2015
Last Update Posted: August 24, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Signe Vahlkvist, Hospital of South West Denmark
  Purpose

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 Intervention Phase
Respiratory Syncytial Virus Bronchiolitis Device: Optiflow Junior Device: Continous Positive Airway Pressure Phase 4

Study Type: Interventional
Study Design: 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.

Further study details as provided by Signe Vahlkvist, Hospital of South West Denmark:

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

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

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

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

  • 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.

  • 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


Estimated Enrollment: 48
Study Start Date: December 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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


Contacts
Contact: Signe Vahlkvist, MD PhD +4522334666 Signevv@gmail.com

Locations
Denmark
Signe Vahlkvist Recruiting
Kolding, Denmark, 6000
Contact: Signe Vahlkvist, MD Ph.D    +4522334666    Signevv@gmail.com   
Sponsors and Collaborators
Hospital of South West Denmark
Investigators
Principal Investigator: Signe VAhlkvist, MD PhD Pediatric Award, Hospital of South West Denmark
  More Information

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 Submitted: November 25, 2015
First Posted: December 1, 2015
Last Update Posted: August 24, 2017
Last Verified: August 2017

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