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NCT06074185CompletedPhase 2

Treating Respiratory Emergencies in Children Study

Source: ClinicalTrials.gov · Last updated 24 Apr 2026

Brief summary (registry, in English)

Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to be hospitalized, thereby facilitating earlier return to normal daily activities. Preliminary data from one site found hospital admission was reduced from 30% to 21% among children when an EMS system introduced a pediatric asthma protocol with oral dexamethasone. The current standard for Emergency Department (ED) treatment for acute wheezing for children two and older includes inhaled ipratropium and dexamethasone. These treatments have a longstanding history of safety and are effective in preventing hospitalization when used early in the ED. Specific treatment protocols generally direct prehospital care. Ipratropium and dexamethasone are recommended by national EMS organizations that develop model protocols for prehospital care. However, only 25% of EMS agencies from large US metropolitan areas allow ipratropium, and only 10% include dexamethasone in their treatment protocols. A clinical trial is critically needed to evaluate whether the significant EMS resources required to implement interventions for children with life-threatening wheezing that have proven benefit in the ED result in improved patient outcomes. The overall objective of this three-site pilot trial is to address specific questions related to the implementation of the study and ensure its feasibility. The study will be conducted in the Pediatric Emergency Care Applied Research Network (PECARN) EMS Affiliates (EMSAs). The investigators will include patients aged 2-17 who have a 911 call for acute life-threatening wheezing. The specific aims are 1) to develop and produce a prehospital checklist for the treatment bundle, including ipratropium and dexamethasone, 2) to determine the feasibility of collecting patient outcomes for wheezing children treated in the EMS system, and 3) to evaluate the implementation of the EMS treatment bundle and checklist using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our overall hypothesis is that the study will be feasible to implement. This study will provide the necessary data to ensure the eventual trial is feasible, primarily by establishing the ability to measure the outcomes of interest as well as evaluating implementation. This study is innovative by focusing on pediatric care in the prehospital environment, a critical component of our emergency care system that is often neglected in research.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
44 (actual)
First submitted
10 Aug 2023
Start date
19 Jan 2024
Primary completion date
28 Feb 2025
Lead sponsor
Oregon Health and Science University
Diseases
Asthma
NCT number
NCT06074185

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 44
  • From 19 Jan 2024 to the primary completion date, 28 Feb 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Parent, legally authorized representative (LAR), subject, and/or family member objects to participation prior to treatment

Other illness

  • History of albuterol, ipratropium, or dexamethasone allergy

Other

  • Known or suspected pregnancy
  • Prisoner
  • Croup
  • Suspected airway foreign body
  • Respiratory distress not due to bronchospasm/wheeze

Who the study is looking for

  • Ages 2-17 years; AND
  • Transported by EMS through 911 activation; AND
  • Prior history of wheeze/asthma, current asthma symptoms (dyspnea or wheeze); AND
  • At least 4 of the following:
    • Visible use of accessory muscles/retractions
    • Inspiratory and expiratory wheezing or silent chest
    • Abnormal respiratory rate for age
    • For \< 6 years ≥ 46 breaths/min
    • For ≥ 6 years ≥ 36 breaths/min
    • Agitation, drowsiness, or confusion
    • Oxygen saturation \< 93% on room air

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University at Buffalo
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status
Mecklenburg County EMS
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.