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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: Clinical Trial NA study, sponsored by University of Texas Southwestern Medical Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%. The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis. To determine RACS: * A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit. * Subsequent RDAI score is subtracted from the previous RDAI score to
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 |
Why NCT04517344 stopped before completion
NCT04517344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Initial Flow Rate is the first listed.
NCT04517344 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04517344's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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