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NCT04517344 · ClinicalTrials.gov registry record · NA
High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04517344 is a NA study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 21 participants.
The verdict
NCT04517344, a NA study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care. The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.
Interventions
- OTHER Initial Flow Rate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2025-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04517344
The ClinicalTrials.gov registry entry for NCT04517344 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Initial Flow Rate is the first listed.
NCT04517344 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04517344 about?
NCT04517344 is a clinical study titled "High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study". The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 202...
What is the current status of trial NCT04517344?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2020-12-01. Estimated completion is 2025-04-01.
What interventions are being tested in trial NCT04517344?
The interventions under investigation include: Initial Flow Rate (OTHER).
Who is sponsoring clinical trial NCT04517344?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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