Phase 4
N=834
Early Administration of Steroids in the Ambulance Setting
Asthma in Children
Bottom Line
View on ClinicalTrials.gov: NCT03962894 ↗Enrolled (actual)
834
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Hospital Admission — 57; 208 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisolone (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Admission |
57; 208 | — |
| SECONDARY Emergency Department Length-of-stay |
168; 159 | — |
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.
Eligibility Criteria
Inclusion Criteria
- primary problem: Asthma exacerbation
- stable to take an oral medication
- transported by EMS to an ED
Exclusion Criteria
- unconscious, hemodynamically unstable, or critically ill -> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)
- daily or every other day corticosteroid therapy
- 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
Data sourced from ClinicalTrials.gov (NCT03962894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.