CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 834 enrolled
Drug / intervention
Prednisolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03962894
NCT03962894Phase 4Completed

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

University of Florida·interventional·Posted May 24, 2019·Updated May 8, 2025

In Brief

A Phase 4 clinical trial evaluating Prednisolone for Asthma in Children. Completed, enrolled 834 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMay 24, 2019
Enrollment StartApr 1, 2019
Primary CompletionMay 31, 2024
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.1 years ago

Interventions

Prednisolonedrug

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.