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High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study
N/A
Waitlist Available
Led By Amy Cheng, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours from time of study
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing different oxygen flow rates in infants with severe bronchiolitis. The therapy helps these infants breathe easier by delivering a steady flow of oxygen through their nose. The goal is to find the best flow rate that improves their breathing the most. This method has been widely used in recent years for respiratory support in infants with bronchiolitis.
Eligible Conditions
- Bronchiolitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours from time of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours from time of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment response to HFNC Therapy
Secondary study objectives
Length of oxygen support
Length of stay
Treatment failure to HFNC Therapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3, HFNC 2 L/kg/minExperimental Treatment1 Intervention
The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
Group II: Arm 2, HFNC 1.5 L/kg/minExperimental Treatment1 Intervention
The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
Group III: Arm 1, HFNC 1 L/kg/minExperimental Treatment1 Intervention
The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is \<90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,578 Total Patients Enrolled
1 Trials studying Bronchiolitis
52 Patients Enrolled for Bronchiolitis
Amy Cheng, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center