# Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial

## TL;DR

A study found that reusing bubble CPAP systems for preterm babies does not increase sepsis risk, supporting their potential for wider use in resource-limited settings.

## Contribution

The study demonstrates that reprocessed bCPAP systems are safe in terms of sepsis risk, offering a novel solution to improve access to neonatal respiratory care.

## Key findings

- No significant differences in death or escalation of care were observed between the MV-CPAP and reprocessed bCPAP groups.
- The composite outcome of treatment escalation or death had an odds ratio of 0.84 with no statistical significance.
- Reprocessed bCPAP systems did not increase the risk of neonatal sepsis compared to single-use systems.

## Abstract

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 cleaned and disinfected after each use. The primary outcome was a composite of treatment escalation or death.

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.

Use of a reprocessed bCPAP system designed to increase global access to CPAP did not increase rates of neonatal sepsis.

ClinicalTrials.gov, identifier, (NCT06082674).