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NCT06074185 · ClinicalTrials.gov registry record · Phase 2
Treating Respiratory Emergencies in Children Study
A Phase 2 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT06074185 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 44 participants.
The verdict
NCT06074185, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to be hospitalized, thereby facilitating earlier return to normal daily activities. Preliminary data from one site found hospital admission was reduced from 30% to 21% among children when an EMS system introduced a pediatric asthma protocol with oral dexamethasone. The current standard for Emergency Department (ED) treatment for acute wheezing for children two and older includes inhaled ipratropium and dexamethasone. These treatments have a longstanding history of safety and are effective in preventing hospitalization when used early in the ED. Specific treatment protocols generally direct prehospital care. Ipratropium and dexamethasone are recommended by national EMS organizations that develop model protocols for prehospital care. However, only 25% of EMS agencies from large US metropolitan areas allow ipratropium, and only 10% include dexamethasone in their treatment protocols. A clinical trial is critically needed to evaluate whether the significant EMS resources required to implement interventions for children with life-threatening wheezing that have proven benefit in the ED result in improved patient outcomes. The overall objective of this three-site pilot trial is to address specific questions related to the implementation of the study and ensure its feasibility. The study will be conducted in the Pediatric Emergency Care Applied Research Network (PECARN) EMS Affiliates (EMSAs). The investigators will include patients aged 2-17 who have a 911 call for acute life-threatening wheezing. The specific aims are 1) to develop and produce a prehospital checklist for the treatment bundle, including ipratropium and dexamethasone, 2) to determine the feasibilit
Interventions
- DRUG Ipratropium Bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2024-01-19 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06074185
The ClinicalTrials.gov registry entry for NCT06074185 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ipratropium Bromide is the first listed.
NCT06074185 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06074185 about?
NCT06074185 is a clinical study titled "Treating Respiratory Emergencies in Children Study". Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and ...
What is the current status of trial NCT06074185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2024-01-19. Estimated completion is 2025-03-11.
What interventions are being tested in trial NCT06074185?
The interventions under investigation include: Ipratropium Bromide (DRUG).
Who is sponsoring clinical trial NCT06074185?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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