NCT03962894CompletedPhase 4
Early Administration of Steroids in the Ambulance Setting
Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 834 (actual)
- First submitted
- 22 May 2019
- Start date
- 1 Apr 2019
- Primary completion date
- 31 May 2024
- Lead sponsor
- University of Florida
- Diseases
- Asthma
- NCT number
- NCT03962894
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 834
- From 1 Apr 2019 to the primary completion date, 31 May 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- daily or every other day corticosteroid therapy
Other illness
- allergy to prednisolone or another corticosteroid
- chronic lung disease besides asthma, airway anatomic abnormalities, tracheostomy, immunocompromised, traumatic injury, pregnancy, law enforcement custody, non-English speaking
Other
- unconscious, hemodynamically unstable, or critically ill -\> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
Who the study is looking for
- primary problem: Asthma exacerbation
- stable to take an oral medication
- transported by EMS to an ED
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Walton County EMS Coordinator of this site? Confirm its status | DeFuniak Springs | United States | Unknown status |
| Lee County Public Safety & Emergency Services Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Texas Children's Hospital / UT Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Sarasota County EMS Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Leon County EMS Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| Nassau County Fire Rescue Department Coordinator of this site? Confirm its status | Yulee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.