Fact CheckerSign in

NCT03962894CompletedPhase 4

Early Administration of Steroids in the Ambulance Setting

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

Source: ClinicalTrials.gov · Last updated 8 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
834 (actual)
First submitted
22 May 2019
Start date
1 Apr 2019
Primary completion date
31 May 2024
Lead sponsor
University of Florida
Diseases
Asthma
NCT number
NCT03962894

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 834
  • From 1 Apr 2019 to the primary completion date, 31 May 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • daily or every other day corticosteroid therapy

Other illness

  • 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

Other

  • unconscious, hemodynamically unstable, or critically ill -\> EMS will proceed with usual critical care (includes IV methylprednisolone as per protocol)

Who the study is looking for

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

Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cincinnati Children's Hospital
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Walton County EMS
Coordinator of this site? Confirm its status
DeFuniak SpringsUnited StatesUnknown status
Lee County Public Safety & Emergency Services
Coordinator of this site? Confirm its status
Fort MyersUnited StatesUnknown status
Texas Children's Hospital / UT Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Sarasota County EMS
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status
Leon County EMS
Coordinator of this site? Confirm its status
TallahasseeUnited StatesUnknown status
Nassau County Fire Rescue Department
Coordinator of this site? Confirm its status
YuleeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.