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Initial Flow Rate for Bronchiolitis

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
Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours from time of study
Awards & highlights

Study Summary

This trial is testing whether high-flow nasal cannula (HFNC) therapy can help treat moderate to severe bronchiolitis in children less than 12 months old. The study will compare HFNC therapy at three different flow rates to see which is most effective. The primary outcome is a change in the Respiratory Assessment Change Score (RACS) after four hours of therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have symptoms of moderate to severe bronchiolitis as defined by the American Academy of Pediatrics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours from time of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours from time of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment response to HFNC Therapy
Secondary outcome measures
Length of oxygen support
Length of stay
Treatment failure to HFNC Therapy

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 %.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,015 Total Patients Enrolled
1 Trials studying Bronchiolitis
52 Patients Enrolled for Bronchiolitis
Amy Cheng, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation offer recruitment opportunities to those over seventy years of age?

"The requirements for this clinical trial necessitate that the participants are between 7 Days and 12 Months old. Additionally, 24 trials exist to serve people who are younger than 18 years of age while there are 18 studies specifically targeting those over 65."

Answered by AI

What criteria must prospective volunteers meet to partake in this clinical experiment?

"This medical study is seeking 84 volunteers with bronchiolitis that fall between 7 days and 12 months old. Candidates must meet these criteria in order to participate."

Answered by AI

Are there still opportunities available for individuals to participate in this research?

"The trial is still actively recruiting, as indicated on clinicaltrials.gov; it was first published in December of 2020 and the most recent update was released in June 2022."

Answered by AI

How many participants are currently accepted into this medical research?

"Affirmative. According to information retrieved from clinicaltrials.gov, this medical study is open for recruitment and was first advertised on December 1st 2020. The last update occurred at the end of June 2022 with 84 participants required from a single site."

Answered by AI
~0 spots leftby Apr 2024