O3010: Ideal Steroids for Asthma Treatment in the PICU (iSTAT PICU): A Single-center, Open-label, Two-arm, Parallel-group, Nonrandomized Clinical Trial

Background: While methylprednisolone (MP) is commonly used in the pediatric intensive care unit (PICU) for children with critical asthma (CA), retrospective data suggest equipoise for dexamethasone (DM) treatment. No comparative effectiveness data exists derived from prospective trials. We aimed to assess efficacy and safety endpoints among children with CA receiving standardized dosing of MP versus DM.

Methods: We performed a prospective, single center, open-label, two-arm, parallel-group, nonrandomized clinical trial (NCT#03900624, IRB#00187813) among children 5-17 years of age hospitalized for CA from April 2019-December 2021. After consent, participants entered groups (1:2 ratio) receiving intravenous DM (0.25 mg/kg/dose q6 for 2-days [max:15mg/dose]) and intravenous MP (0.5 mg/kg/dose q6 for 5-days [max:60mg/dose]). Efficacy endpoints were PICU length of stay, continuous albuterol duration, composite rates of adjunctive asthma treatment, and same-cause hospital readmission rates. Safety endpoints were corticosteroid adverse effects and extended glucocorticoid exposure (>5 days).

Results: Of the 92 participants enrolled, 31 received DM and 61 MP. There were no differences in demographics, comorbidities, or asthma severity indices (Table 1). No detectable differences in efficacy and safety endpoints were observed (Table 2). Compared to the MP group, the DM group were less frequently transitioned to enteral glucocorticoids (74% versus 92%) and less commonly prescribed glucocorticoids at discharge (13% versus 72%).

Conclusion: In this prospective clinical trial, children with CA provided DM had comparable outcomes to those prescribed MP. Given the shorter duration of drug exposure and less frequent discharge prescribing rates, we advocate for DM as an alternative to MP for pediatric CA.