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NCT03962894 · ClinicalTrials.gov registry record · Phase 4
Early Administration of Steroids in the Ambulance Setting
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 834
- Enrollment target
NCT03962894 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 834 participants.
The verdict
NCT03962894, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 834 participants
- Enrollment target
Study Summary
Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-sensitive, decreases in hospital admissions and ED length-of-stay (LOS). For patients who are treated by 911 emergency medical services (EMS) first, there exists an opportunity for even earlier administration of CS, prior to ED arrival. Yet, preliminary data demonstrate that currently less than 10% of EMS pediatric asthma patients receive CS prior to ED arrival. Given the known time-sensitivity of CS' effects on patient outcomes, the investigators hypothesize that even earlier EMS administration of CS will decrease hospital admissions, ED LOS, and intensive care unit admissions for pediatric patients with an acute asthma exacerbation. Using a pragmatic observation design in multiple EMS agencies, we will enroll patients to analyze clinical outcomes and comparative costs of EMS CS administration, and how both are influenced by EMS transport time. That novel combination of analyses will help build evidence-based guidelines adaptable for diverse EMS agencies nationwide.
Interventions
- DRUG Prednisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 834 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03962894
The ClinicalTrials.gov registry entry for NCT03962894 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 834 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prednisolone is the first listed.
NCT03962894 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03962894 about?
NCT03962894 is a clinical study titled "Early Administration of Steroids in the Ambulance Setting". Asthma is the most common chronic disease of childhood and is a leading cause of emergency medical treatment. For children experiencing an asthma exacerbation, emergency department (ED) guidelines recommend early systemic corticosteroid (CS) administration, since studies have shown associated, time-...
What is the current status of trial NCT03962894?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 834 participants. The study started on 2019-04-01. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT03962894?
The interventions under investigation include: Prednisolone (DRUG).
Who is sponsoring clinical trial NCT03962894?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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