NCT03962894

Early Administration of Steroids in the Ambulance Setting

Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
DRUG	Prednisolone	During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-05-31
• Completion: 2024-12-31
• First posted: 2019-05-24
• Last updated: 2025-05-08
• Results posted: 2024-10-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study