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Early Administration of Steroids in the Ambulance Setting (EASI-AS-ODT)

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ClinicalTrials.gov Identifier: NCT03962894
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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, cluster randomized controlled trial (RCT) design, this study will fill a significant knowledge gap in the EMS care of pediatric asthma. Through the study team's partnership with Lee County EMS agency, it is planned to enroll a total of 300 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.


Condition or disease Intervention/treatment
Asthma in Children Drug: Prednisolone

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Administration of Steroids in the Ambulance Setting: An Observational Design Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Early Prehospital Systemic Corticosteroids
Children with asthma attacks who receive systemic corticosteroids in the prehospital environment by emergency medical services
Drug: Prednisolone
During a sequenced rollout protocol change for Lee County EMS, certain ambulance stations who are randomized to early adoption of an upcoming protocol change will administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. Ambulance randomized to later protocol adoption will continue usual care, until the end of the study when all ambulance stations adopt the new protocol with early administration of prednisolone

Usual Care
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



Primary Outcome Measures :
  1. Hospital Admission [ Time Frame: Day 1 (ED stay) ]
    Number of admissions to an inpatient unit (general or ICU) for an asthma exacerbation


Secondary Outcome Measures :
  1. Emergency Department length-of-stay [ Time Frame: Day 1 (from EMS arrival to ED discharge) ]
    Length of time in emergency department for patients who are discharged home



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children ages 2-18 years of age experiencing an acute asthma attack who are treated by EMS and transported to an ED.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962894


Contacts
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Contact: Jennifer Fishe, MD 904-244-5812 Jennifer.fishe@jax.ufl.edu
Contact: Michelle Lott Michelle.Lott@jax.ufl.edu

Locations
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United States, Florida
Lee County Public Safety & Emergency Services Not yet recruiting
Fort Myers, Florida, United States, 33905
Contact: Benjamin Abes    239-533-3911    Benjamin.Abes@leegov.com   
Contact: Jennifer Fishe, MD    804-931-7567    Jennifer.Fishe@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Jennifer Fishe, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03962894     History of Changes
Other Study ID Numbers: IRB201901351
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents