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High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis

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ClinicalTrials.gov Identifier: NCT03252119
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Susan Murphy, Chris Hani Baragwanath Academic Hospital

Brief Summary:
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".

Condition or disease Intervention/treatment Phase
Bronchiolitis, Viral Device: High flow humidified oxygen therapy Not Applicable

Detailed Description:
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: standard therapy group
standard treatment of viral bronchiolitis with low flow oxygen.
Experimental: high flow humidified oxygen group
treatment of viral bronchiolitis with high flow humidified oxygen therapy.
Device: High flow humidified oxygen therapy
application of high flow humidified oxygen therapy at 2l/kg/min




Primary Outcome Measures :
  1. Effect of high flow humidified oxygen therapy on work of breathing [ Time Frame: during first 5 days post enrollment ]
    Respiratory rate (n/min)

  2. Effect of high flow humidified oxygen therapy on work of breathing [ Time Frame: first 5 days post enrollment ]
    Use of accessory muscles of respiration (present /not)

  3. Effect of high flow humidified oxygen therapy on blood oxygen saturations [ Time Frame: first 5 days post enrollment ]
    Saturation of oxygen (% saturation) as measured by pulse oximeter

  4. Effect of high flow humidified oxygen therapy on heart rate [ Time Frame: first 5 days post enrollment ]
    Pulse (n/min) measured by ECG monitor


Secondary Outcome Measures :
  1. Proportion of patients requiring intubation and ventilation [ Time Frame: from time of enrollment to end of hospital stay (up to 6 months) ]
    number of patients (N) getting intubated

  2. Length of hospital stay [ Time Frame: from time of enrollment to end of hospital stay (up to 6 months) ]
    days (N) spent in hospital



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Ages Eligible for Study:   1 Month to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of viral bronchiolitis
  • Not requiring intubation and ventilation
  • Admitted to high care unit
  • With moderate/severe respiratory distress (Tal score >6)
  • Saturations <92% in room air

Exclusion Criteria:

  • congenital cardiac disease
  • presence of multiorgan failure/multisystemic disease
  • previously ventilated
  • craniofacial abnormalities
  • nasal pathology
  • decreased level of consciousness
  • Ex-prem <34 weeks
  • Possible impending respiratory failure

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): NCT03252119


Contacts
Contact: Susan M Murphy, FCPaed (SA) +27847009136 Susan.Murphy@wits.ac.za

Locations
South Africa
Chris Hani Baragwanath Academic Hospital Recruiting
Johannesburg, Gauteng, South Africa
Contact: Susan M Murphy, FCPaed (SA)    +27 119330270    Susan.Murphy@wits.ac.za   
Sub-Investigator: Linda G Doedens, FCPaed         
Principal Investigator: Susan M Murphy, FCPaed         
Sub-Investigator: Asma Salloo, FCPaed         
Sub-Investigator: Ayesha Khan, FCPaed         
Sub-Investigator: Eduard Bruckmann, FCPaed         
Sponsors and Collaborators
Chris Hani Baragwanath Academic Hospital
Investigators
Principal Investigator: Susan M Murphy, FCPaed (SA) University of the Witwatersrand, Johannesburg

Responsible Party: Susan Murphy, Specialist Intensivist, Chris Hani Baragwanath Academic Hospital
ClinicalTrials.gov Identifier: NCT03252119     History of Changes
Other Study ID Numbers: M170234
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data wit other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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