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NCT04064684 · ClinicalTrials.gov registry record · Phase 2
Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT04064684 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 2 participants.
The verdict
NCT04064684, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).
Interventions
- DRUG Placebo
- DRUG Budesonide
- DEVICE Nebulizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2020-03-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04064684
The ClinicalTrials.gov registry entry for NCT04064684 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04064684 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04064684 about?
NCT04064684 is a clinical study titled "Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome". The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevanc...
What is the current status of trial NCT04064684?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2020-02-04. Estimated completion is 2020-03-30.
What interventions are being tested in trial NCT04064684?
The interventions under investigation include: Placebo (DRUG), Budesonide (DRUG), Nebulizer (DEVICE).
Who is sponsoring clinical trial NCT04064684?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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