CLINICAL TRIAL article

Front. Pediatr.

Sec. Neonatology

Volume 13 - 2025 | doi: 10.3389/fped.2025.1569437

Evaluation of a Novel Reprocessed bCPAP System on Sepsis Rates Among Preterm Neonates with Respiratory Distress: A Randomized Controlled Trial

Provisionally accepted
  • 1Vayu Global Health Foundation, Boston, United States
  • 2Ilocos Training and Regional Medical Center, San Fernando City, Philippines
  • 3Mariano Marcos State University, Batac, Philippines
  • 4Massachusetts General Hospital, Boston, Massachusetts, United States
  • 5Harvard Medical School, Boston, Massachusetts, United States
  • 6School of Public Health, Harvard University, Boston, Massachusetts, United States

The final, formatted version of the article will be published soon.

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.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 reprocessed 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.

Keywords: neonate, BCPAP, reuse, Neonatal sepsis, Respiratory distress

Received: 31 Jan 2025; Accepted: 30 Apr 2025.

Copyright: © 2025 Badin, Roodaki, Garcia, Abila-Cariaga and Burke. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Sarah Badin, Vayu Global Health Foundation, Boston, United States

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