Bilevel Positive Airway Pressure and Continuous Albuterol for Pediatric Asthma Exacerbations: A Randomized Clinical Trial.

IMPORTANCE: A substantial knowledge gap remains in understanding the specific role bilevel positive airway pressure (BPAP) in the emergency department (ED) for acute pediatric asthma exacerbations. OBJECTIVE: To examine whether the early application of BPAP in the ED for acute pediatric asthma exacerbations reduces duration of critical care management time. DESIGN, SETTING, AND PARTICIPANTS: This double-blind randomized clinical trial enrolled children between 5 and 17 years of age presenting to a single-center, quaternary, referral pediatric ED with an acute asthma exacerbation, a pediatric respiratory assessment measure of at least 4 (moderate severity), and prescribed continuous albuterol therapy between June 1, 2023, and May 31, 2025. INTERVENTION: Participants were randomized to either the intervention arm (BPAP) or control arm (sham BPAP, which delivers minimal pressure) for 4 hours. Neither the health care practitioners nor participants were aware of study arm allocation. MAIN OUTCOME AND MEASURES: The primary outcome measure was duration of continuous albuterol therapy. A sequential design with a planned interim analysis for futility and superiority was used, and a t test compared mean duration of continuous β-agonist therapy under an intention-to-treat approach. RESULTS: Sixty-six study participants (median [IQR] age, 10.2 [6.8-13.2] years; 35 [53.0%] male; 1 [1.5%] American Indian or Alaskan, 1 [1.5%] Asian, 21 [31.8%] Black or African American, 21 [31.8%] White, and 22 [33.3%] other race) were included in the primary analysis, with a mean (SD) pediatric respiratory assessment measure of 5.2 (1.9), indicating moderate disease. At the 50% interim analysis, participants in the BPAP study arm received a mean (SD) of 8.3 (8.5) hours of continuous albuterol vs 8.7 (10.0) hours in the control group (mean difference, -0.5 hours; 95% CI, -5.0 to 4.1 hours; P = .84). The study was stopped due to meeting a priori bounds for futility at the 50% interim analysis. No deaths, invasive mechanical ventilation, air leak syndrome, or aspiration pneumonia were observed in either study arm. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of early initiation of BPAP in the ED, no clinically significant decrease in the duration of continuous β-agonist therapy in pediatric patients presenting with moderate asthma exacerbations was observed. Additional open-label studies in a more severe asthma cohort are required to better inform clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05848115.