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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: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT04064684 stopped before completion
NCT04064684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04064684 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04064684's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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