TERMINATED

BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are: 1. Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy. 2. Whether early BiPAP changes how the lungs function in children with asthma attacks. 3. Whether children receiving early BiPAP experience more issues or side effects than those children who do not. All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team. Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.

Official Title

Understanding the Role of Bilevel Positive Airway Pressure (BiPAP) in Pediatric Acute Asthma Exacerbations: A Prospective, Randomized, Double Blind, Controlled Trial

Quick Facts

Study Start:2023-06-23
Study Completion:2025-07-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05848115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation
  2. * Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
  3. * PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy
  1. * Prior participation in the study
  2. * Hypercapnic (PaCO2 \> 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
  3. * Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) \> 0.35)
  4. * Presence of a tracheostomy or baseline noninvasive ventilation requirement
  5. * Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis
  6. * Absolute or relative contraindication to BiPAP: facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy

Contacts and Locations

Principal Investigator

Patrick T Wilson, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Childrens Hospital Colorado
Denver, Colorado, 80238
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Patrick T Wilson, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-23
Study Completion Date2025-07-07

Study Record Updates

Study Start Date2023-06-23
Study Completion Date2025-07-07

Terms related to this study

Keywords Provided by Researchers

  • Pediatric Asthma
  • Asthma
  • Bi-level Positive Airway Pressure
  • BiPAP
  • Beta-Agonist

Additional Relevant MeSH Terms

  • Asthma in Children