Early Administration of Steroids in the Ambulance Setting

NCT03962894 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB201901351 -N-A1K23HL149991-01
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 7

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Hospital Admission

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

  Day 1 (ED stay)

Secondary Outcomes (1)

• Emergency Department Length-of-stay

  Day 1 (from EMS arrival to ED disposition)

Study Arms (2)

Early Prehospital Systemic Corticosteroids

EXPERIMENTAL

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

Drug: Prednisolone

Usual Care

NO INTERVENTION

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

Interventions

Prednisolone DRUG

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.

Early Prehospital Systemic Corticosteroids

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

Walton County EMS

DeFuniak Springs, Florida, 32433, United States

Location

Lee County Public Safety & Emergency Services

Fort Myers, Florida, 33905, United States

Location

Sarasota County EMS

Sarasota, Florida, 34236, United States

Location

Leon County EMS

Tallahassee, Florida, 32301, United States

Location

Nassau County Fire Rescue Department

Yulee, Florida, 32097, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Texas Children's Hospital / UT Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jennifer Fishe
• Organization: University of Florida

Jennifer.Fishe@jax.ufl.edu

904-244-4046

Study Officials

• Jennifer Fishe, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 24, 2019
• Study Start: April 1, 2019
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2025
• Results First Posted: October 24, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)