Badin Sarah, Roodaki Navid, Garcia Daisy Evangeline C, Abila-Cariaga Rochelle, Burke Thomas F
Department of Implementation, Vayu Global Health Foundation, Medford, MA, United States.
Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA, United States.
Front Pediatr. 2025 May 19;13:1569437. doi: 10.3389/fped.2025.1569437. eCollection 2025.
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 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, = 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).
鼻塞式持续气道正压通气（bCPAP）在治疗早产儿呼吸窘迫综合征及新生儿其他原因导致的呼吸功能不全方面非常有效。为克服使用bCPAP的障碍，研发了一种新型系统，该系统设计为可清洗、消毒并重复使用。本研究评估了重复使用的bCPAP系统是否会增加新生儿败血症的发生率。
对一项单中心随机对照试验（注册号：NCT06082674）进行分析，该试验将机械通气驱动的CPAP设备（MV-CPAP）与一次性回路与每次使用后清洗消毒的可重复使用bCPAP系统进行比较。主要结局是治疗升级或死亡的复合结局。
75名新生儿被随机分配到两个CPAP治疗组。MV-CPAP组和bCPAP组在死亡（5例对4例）、护理升级（10例对9例）和复合结局（OR = 0.84；95%CI：0.30 - 2.35，P = 0.743）方面均未检测到显著差异。任何次要结局均无临床显著差异。
使用旨在增加全球CPAP可及性的重复使用bCPAP系统并未增加新生儿败血症的发生率。
ClinicalTrials.gov，标识符，（NCT06082674）。
