BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

NCT05848115 | Terminated DMC FDA Device

• 2 other identifiers: 22-23381R61HL158814-01A1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Whether early BiPAP changes how the lungs function in children with asthma attacks.
3. 3.Whether children receiving early BiPAP experience more issues or side effects than those children who do not.

Conditions

Asthma in Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Duration of Continuous Beta-Agonist Therapy

  Number of hours until discontinuation of continuous beta-agonist therapy

  Through study completion, an average of 24 hours

Secondary Outcomes (10)

• Change in Pediatric Respiratory Assessment Measure (PRAM)

  At two and four hours after starting the intervention

• Change in Respiratory Rate

  At two and four hours after starting the intervention

• Invasive Mechanical Ventilation

  Four-hour study intervention

• Admission to Pediatric Intensive Care Unit (PICU)

  Through entire hospitalization, an average of 72 hours

• Total Length of Stay in Hospital

  Through entire hospitalization, an average of 72 hours

Study Arms (2)

BiPAP

EXPERIMENTAL

Patients randomized to the study group (BiPAP) will receive continuous nebulized albuterol through the FDA approved Respironics Trilogy BiPAP machine as per routine practice and institutional guidelines for albuterol dosing. Participants will receive BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician.

Device: Bi-level Positive Airway Pressure

Control

SHAM COMPARATOR

Patients randomized to the control group (sham BiPAP) will receive continuous nebulized albuterol through the same set-up as the study group and institutional guidelines for albuterol dosing. Participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy per the treating clinician.

Device: Sham Bi-level Positive Airway Pressure

Interventions

Bi-level Positive Airway Pressure DEVICE

An appropriately sized vented BiPAP face mask with a good seal will be applied and monitored by trained respiratory therapists. Patients will be started on an inspiratory peak airway pressure (IPAP) of 10 cm of water and expiratory positive airway pressure (EPAP) of 5 cm of water per Children's Hospital Colorado (CHCO) clinical pathway. BiPAP pressures will be titrated to effect per the treating physician, using assessment of physical examination, vitals, and asthma score per institutional clinical pathway. Study participants will remain on BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the ongoing use of BiPAP or not.

Also known as: BiPAP

BiPAP

Sham Bi-level Positive Airway Pressure DEVICE

The sham BiPAP will have pressure attenuated using an orifice restrictor as described in previous double blinded studies using sham non-invasive ventilation. With this set-up pressures no greater than 2 cm of water have been documented at the location of the face mask. This will ensure that the patient is not receiving positive pressure with any effectiveness or deleterious effects. Study participants will remain on sham BiPAP for four hours or until weaned off continuous beta-agonist therapy by the treating clinician. After the four-hour intervention period, it is at the discretion of the treating clinician regarding the use of BiPAP or not.

Also known as: Sham BiPAP

Control

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation
• Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
• 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

You may not qualify if:

• Prior participation in the study
• Hypercapnic (PaCO2 \> 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
• Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) \> 0.35)
• Presence of a tracheostomy or baseline noninvasive ventilation requirement
• Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Childrens Hospital Colorado

Denver, Colorado, 80238, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Patrick T Wilson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: June 23, 2023
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)