Early Administration of Steroids in the Ambulance Setting

Phase 4

Completed

• Conditions: Asthma in Children
• Interventions: Drug: Prednisolone

• Registration Number: NCT03962894
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-24
• Primary Completion: 2024-05-31
• Results First Submitted: 2024-08-07
• Results First Submitted QC: 2024-10-02
• Results First Posted: 2024-10-24
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Prehospital Systemic Corticosteroids	Prednisolone	Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services

Primary Outcome Measures

Name	Time	Method
Hospital Admission	Day 1 (ED stay)	Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation

Secondary Outcome Measures

Name	Time	Method
Emergency Department Length-of-stay	Day 1 (from EMS arrival to ED disposition)	Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)

Trial Locations

Locations (7)

Walton County EMS; 🇺🇸 DeFuniak Springs, Florida, United States

Nassau County Fire Rescue Department; 🇺🇸 Yulee, 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

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Texas Children's Hospital / UT Houston; 🇺🇸 Houston, Texas, United States