Treating Respiratory Emergencies in Children Study

NCT06074185 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 00138724
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Admitted to the Hospital in Each Group

  Whether or not the patient was admitted to the hospital after the index EMS encounter

  Within 24 hours of the index EMS encounter

Secondary Outcomes (1)

• NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale

  6-8 days after the index EMS encounter

Study Arms (2)

Continue current care

NO INTERVENTION

In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes.

Treatment bundle and checklist

EXPERIMENTAL

In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes.

Drug: Ipratropium Bromide

Interventions

Ipratropium Bromide DRUG

The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.

Also known as: dexamethasone

Treatment bundle and checklist

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of albuterol, ipratropium, or dexamethasone allergy
• Known or suspected pregnancy
• Prisoner
• Croup
• Suspected airway foreign body
• Respiratory distress not due to bronchospasm/wheeze
• Parent, legally authorized representative (LAR), subject, and/or family member objects to participation prior to treatment

Sponsors & Collaborators

• Wake Forest University Health Sciences: collaborator
• Oregon Health and Science University: lead
• University of Utah: collaborator
• University at Buffalo: collaborator

Study Sites (3)

University at Buffalo

Buffalo, New York, 14261, United States

Location

Mecklenburg County EMS

Charlotte, North Carolina, 28208, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Hansen M, Jacobsen K, Freeman S, Studnek J, Swanson D, Ranjit C, Crady R, Burnett SJ, Clemency B, Becker S, Brant-Zawadzki G, Jung J, Barney B. Treating Respiratory Emergencies in Children Study (T-RECS): A pilot trial of prehospital treatment for life-threatening pediatric asthma. J Asthma. 2026 Apr 6:1-12. doi: 10.1080/02770903.2026.2654585. Online ahead of print.

  PMID: 41943480 DERIVED

MeSH Terms

Interventions

Ipratropium; Dexamethasone

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The study was not originally powered or designed to evaluate these outcomes. Further, the study spanned approximately one year, so seasonal variation in the causes of wheezing could have differed between the phases and impacted the results.

Results Point of Contact

• Title: Dr. Matt Hansen, Professor of Emergency Medicine
• Organization: Oregon Health & Science University

hansemat@ohsu.edu

503-418-2291

Study Officials

• Matthew L Hansen, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a before-and-after study

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: October 10, 2023
• Study Start: January 19, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 11, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)