Front Pediatr. 2025 May 19;13:1569437. doi: 10.3389/fped.2025.1569437. eCollection 2025.
ABSTRACT
INTRODUCTION: Bubble CPAP (bCPAP) is highly effective in the treatment of respiratory distress syndrome of prematurity and other causes of newborn respiratory insufficiency. To overcome barriers to bCPAP access a novel system was developed that is designed to be cleaned, disinfected, and reused. This study evaluated whether use of reprocessed bCPAP systems increases the rate of sepsis in neonates.
METHODS: A post hoc analysis of a single-center randomized controlled trial (registration no. NCT06082674) was conducted that compared mechanical ventilator driven CPAP devices (MV-CPAP) with single-use circuits to reusable bCPAP systems that were cleaned and disinfected after each use. The primary outcome was a composite of treatment escalation or death.
RESULTS: Seventy-five neonates were randomized to the two CPAP treatment arms. No significant differences in death (5 vs. 4), escalation of care (10 vs. 9), and the composite outcome (OR = 0.84; 95% CI: 0.30-2.35, p = 0.743) were detected in the MV-CPAP and bCPAP groups respectively. There were no clinically significant differences in any of the secondary outcomes.
DISCUSSION: Use of a reprocessed bCPAP system designed to increase global access to CPAP did not increase rates of neonatal sepsis.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier, (NCT06082674).
PMID:40458453 | PMC:PMC12127326 | DOI:10.3389/fped.2025.1569437
