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NCT00116584 · ClinicalTrials.gov registry record · Phase 3
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
A Phase 3 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT00116584: Completed Phase 3 study, sponsored by University of Louisville.
NCT00116584 is a Phase 3 study that has completed, run by University of Louisville. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116584, a Phase 3 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
Primary Outcome
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reportin
Interventions
- DRUG heliox
- DRUG oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2004-12 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT00116584 record still lists
NCT00116584 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which heliox is the first listed.
NCT00116584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116584 about?
NCT00116584 is a clinical study titled "Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients". The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-...
What is the current status of trial NCT00116584?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2004-12. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00116584?
The interventions under investigation include: heliox (DRUG), oxygen (DRUG).
Who is sponsoring clinical trial NCT00116584?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00116584's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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