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NCT01951378 · ClinicalTrials.gov registry record · Phase 4
Comparison of Nebulizers in ED in Pediatric Asthma Patients
A Phase 4 study, sponsored by Seton Healthcare Family.
- Terminated
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT01951378: Clinical Trial Phase 4 study, sponsored by Seton Healthcare Family.
NCT01951378 is a Phase 4 study that was terminated before completion, run by Seton Healthcare Family. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01951378, a Phase 4 study, was terminated before completion, sponsored by Seton Healthcare Family.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary objective will be, in an open-label randomized trial, a comparison of emergency department (ED) length of stay (LOS) between children experiencing acute asthma treated with two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need for additional therapies, transfers to a higher level of care, side-effects, and unscheduled return visits
Primary Outcome
The primary endpoint will be mean ED LOS difference between the groups. Using historical data as a guide, we calculated a baseline LOS mean for discharged patients of 181 minutes, and standard deviation (SD) of 83 minutes. For this reason, an interim analysis will be conducted in order to assess a pilot sample for the purpose of estimating these values. 25 subjects in each arm (50 subjects total) will be enrolled during the initial phase of the study. This early phase interim analysis is not pow
Interventions
- DRUG Albuterol
- DEVICE Hudson RCI® nebulizer
- DEVICE NebuTech® HDN® nebulizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
Why NCT01951378 stopped before completion
NCT01951378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Albuterol is the first listed.
NCT01951378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01951378 about?
NCT01951378 is a clinical study titled "Comparison of Nebulizers in ED in Pediatric Asthma Patients". The primary objective will be, in an open-label randomized trial, a comparison of emergency department (ED) length of stay (LOS) between children experiencing acute asthma treated with two different nebulizers. Secondary outcomes will include admission rates, hospital LOS, need for additional therap...
What is the current status of trial NCT01951378?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2013-09. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01951378?
The interventions under investigation include: Albuterol (DRUG), Hudson RCI® nebulizer (DEVICE), NebuTech® HDN® nebulizer (DEVICE).
Who is sponsoring clinical trial NCT01951378?
This trial is sponsored by Seton Healthcare Family, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01951378's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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