Trial Outcomes & Findings for Early Administration of Steroids in the Ambulance Setting (NCT NCT03962894)
NCT ID: NCT03962894
Last Updated: 2025-05-08
Results Overview
Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
834 participants
Primary outcome timeframe
Day 1 (ED stay)
Results posted on
2025-05-08
Participant Flow
There was no recruitment, as this was an observational study of patients who were receiving EMS treatment regardless of the study.
EMS agencies who decided to incorporate oral systemic corticosteroids as part of clinical care were for this study. The study assigned the start date for EMS agencies to include oral systemic corticosteroids. For the purpose of analysis, we treated that as a stepped wedge protocol design. All agencies contributed one year of data for early prehospital systemic corticosteroids, and one year of data for no prehospital systemic corticosteroids.
Unit of analysis: EMS agencies
Participant milestones
| Measure |
Houston EMS Pre and Post-Protocol Change
Children with asthma attacks treated by Houston EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 10/1/2014.
|
Cincinnati EMS Pre- and Post-Protocol Change
Children with asthma attacks treated by Cincinnati EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 1/1/2016.
|
Nassau County FL EMS Pre- and Post- Protocol Change
Children with asthma attacks treated by Nassau County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2019.
|
Lee County FL EMS Pre- and Post- Protocol Change
Children with asthma attacks treated by Lee County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2019.
|
Walton County FL EMS Pre- and Post-Protocol Change
Children with asthma attacks treated by Walton County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 11/1/2020.
|
Leon County FL EMS Pre- and Post-Protocol Change
Children with asthma attacks treated by Leon County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 2/1/2021.
|
Sarasota County FL EMS Pre- and Post-Protocol Change
Children with asthma attacks treated by Sarasota County FL EMS. Data abstracted 12 months before and 12 months after protocol change adding oral systemic corticosteroids that occurred on 6/1/2021/
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
265 1
|
271 1
|
6 1
|
133 1
|
14 1
|
99 1
|
46 1
|
|
Overall Study
COMPLETED
|
265 1
|
271 1
|
6 1
|
133 1
|
14 1
|
99 1
|
46 1
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Administration of Steroids in the Ambulance Setting
Baseline characteristics by cohort
| Measure |
Early Prehospital Systemic Corticosteroids
n=175 Participants
Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
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.
|
Usual Care
n=659 Participants
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
|
Total
n=834 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8 years
n=5 Participants
|
8 years
n=7 Participants
|
8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
386 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
107 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
524 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Bronchodilator Administered
|
159 Participants
n=5 Participants
|
529 Participants
n=7 Participants
|
688 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (ED stay)Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation
Outcome measures
| Measure |
Early Prehospital Systemic Corticosteroids
n=175 Participants
Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services
|
No Early Prehospital Systemic Corticosteroids
n=659 Participants
Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids
|
|---|---|---|
|
Hospital Admission
|
57 Participants
|
208 Participants
|
SECONDARY outcome
Timeframe: Day 1 (from EMS arrival to ED disposition)Length of time in emergency department for patients from arrival to disposition (i.e., length of time for discharge, admission, or transfer to another hospital)
Outcome measures
| Measure |
Early Prehospital Systemic Corticosteroids
n=175 Participants
Children with asthma attacks who receive systemic corticosteroids and bronchodilators in the prehospital environment by emergency medical services
|
No Early Prehospital Systemic Corticosteroids
n=659 Participants
Children with asthma attacks treated by emergency medical services who receive bronchodilators en route to emergency departments, where in the ED they then receive systemic corticosteroids
|
|---|---|---|
|
Emergency Department Length-of-stay
|
168 minutes
Interval 127.0 to 256.0
|
159 minutes
Interval 108.0 to 228.0
|
Adverse Events
Early Prehospital Systemic Corticosteroids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Early Prehospital Systemic Corticosteroids
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place