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Clinical Trials/NCT03962894
NCT03962894
Completed
Phase 4

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

University of Florida7 sites in 1 country834 target enrollmentApril 1, 2019
InterventionsPrednisolone

Overview

Phase
Phase 4
Intervention
Prednisolone
Conditions
Asthma in Children
Sponsor
University of Florida
Enrollment
834
Locations
7
Primary Endpoint
Hospital Admission
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Early Prehospital Systemic Corticosteroids

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

Intervention: Prednisolone

Outcomes

Primary Outcomes

Hospital Admission

Time Frame: Day 1 (ED stay)

Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation

Secondary Outcomes

  • Emergency Department Length-of-stay(Day 1 (from EMS arrival to ED disposition))

Study Sites (7)

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