Early Administration of Steroids in the Ambulance Setting

Asthma in Children Clinical Trial

— EASI-AS-ODT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962894
• Other study ID #: IRB201901351 -N-A
• Secondary ID: 1K23HL149991-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 stepped wedge design in multiple EMS agencies, we will enroll patients over a three-year period 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1464
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma in Children

Intervention

Drug:
• Prednisolone
During a sequenced rollout protocol change for several EMS agencies, those agencies will adopt protocol change to administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Admission	Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation	Day 1 (ED stay)
Secondary	Emergency Department length-of-stay	Length of time in emergency department for patients who are discharged home	Day 1 (from EMS arrival to ED discharge)