Early Administration of Steroids in the Ambulance Setting

Completed · Phase 4

Conditions studied: Asthma in Children

In brief

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.

Key facts

Study ID

NCT03962894

Run by

University of Florida

People needed

834

Starts

2019-04-01

Expected to finish

2024-12-31

Last updated by the study team

2025-05-08

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• primary problem: Asthma exacerbation
• stable to take an oral medication
• transported by EMS to an ED

You may not qualify if…

• 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

Where it is running

• Walton County EMS — DeFuniak Springs, Florida, United States
• Lee County Public Safety & Emergency Services — Fort Myers, Florida, United States
• Sarasota County EMS — Sarasota, Florida, United States
• Leon County EMS — Tallahassee, Florida, United States
• Nassau County Fire Rescue Department — Yulee, Florida, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Texas Children's Hospital / UT Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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