Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)

University of Florida

Status and phase: Completed; Phase 4

Conditions: Asthma in Children

Treatments: Drug: Prednisolone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03962894

1K23HL149991-01 (U.S. NIH Grant/Contract)

IRB201901351 -N-A

Details and patient eligibility

About

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.

Enrollment: 834 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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834 participants in 2 patient groups

Early Prehospital Systemic Corticosteroids

Experimental group

Description:

Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services

Treatment:

Drug: Prednisolone

Usual Care

No Intervention group

Description:

Children with asthma attacks treated by emergency medical services who receive usual care en route to emergency departments, where in the ED they then receive systemic corticosteroids