Study Stopped
Slow recruitment
High Flow Nasal Cannula Use in Infants With Bronchiolitis
High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial
1 other identifier
interventional
18
1 country
4
Brief Summary
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedDecember 19, 2018
December 1, 2018
2.5 years
February 26, 2016
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with treatment failure
Treatment failure = need for change of respiratory support method
720 hours
Secondary Outcomes (5)
Respiratory rate measured by the study physician/nurse
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Oxygen saturation (%)
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from randomisation to end of oxygen therapy
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from hospital admission to discharge (hours)
720 hours
Number of participants needing admission to intensive care unit (ICU)
720 hours
Study Arms (2)
Usual oxygen therapy
ACTIVE COMPARATOROxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
High flow oxygen therapy
EXPERIMENTALHigh flow nasal cannula oxygen therapy with Airvo (TM, Fisher \& Paykel Healthcare) device
Interventions
High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Eligibility Criteria
You may qualify if:
- Admission to pediatric ward due to a presumed viral bronchiolitis
- Need of oxygen therapy (oxygen saturation \< 92%)
You may not qualify if:
- Pertussis
- Needs intubation or CPAP on admission
- Severe congenital heart defect
- Down's syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Central Hospital Jyväskylä
Jyväskylä, Finland
Oulu Unversity Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjo Renko, MD, PhD
University of Oulu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 26, 2016
First Posted
April 13, 2016
Study Start
March 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
December 19, 2018
Record last verified: 2018-12