Clinical trial NCT03962894: Early Administration of Steroids in the Ambulance Setting
Official title: Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma in Children
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-05-24
Enrollment: 834
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hospital Admission
timeFrame: Day 1 (ED stay)
Secondary outcomes:
measure: Emergency Department Length-of-stay
timeFrame: Day 1 (from EMS arrival to ED disposition)
Other outcomes:
Locations:
city: DeFuniak Springs
country: United States
facility: Walton County EMS
state: Florida
city: Fort Myers
country: United States
facility: Lee County Public Safety & Emergency Services
state: Florida
city: Sarasota
country: United States
facility: Sarasota County EMS
state: Florida
city: Tallahassee
country: United States
facility: Leon County EMS
state: Florida
city: Yulee
country: United States
facility: Nassau County Fire Rescue Department
state: Florida
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Houston
country: United States
facility: Texas Children's Hospital / UT Houston
state: Texas
Study officials:
affiliation: University of Florida
name: Jennifer Fishe, MD
role: PRINCIPAL_INVESTIGATOR
References: