Sarah Badin, Navid Roodaki, Daisy Evangeline C Garcia, Rochelle Abila-Cariaga, Thomas F Burke
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The primary outcome was a composite of treatment escalation or death.</p><p><strong>Results: </strong>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, <i>p</i> = 0.743) were detected in the MV-CPAP and bCPAP groups respectively. There were no clinically significant differences in any of the secondary outcomes.</p><p><strong>Discussion: </strong>Use of a reprocessed bCPAP system designed to increase global access to CPAP did not increase rates of neonatal sepsis.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, identifier, (NCT06082674).</p>","PeriodicalId":12637,"journal":{"name":"Frontiers in Pediatrics","volume":"13 ","pages":"1569437"},"PeriodicalIF":2.1000,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12127326/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial.\",\"authors\":\"Sarah Badin, Navid Roodaki, Daisy Evangeline C Garcia, Rochelle Abila-Cariaga, Thomas F Burke\",\"doi\":\"10.3389/fped.2025.1569437\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Bubble CPAP (bCPAP) is highly effective in the treatment of respiratory distress syndrome of prematurity and other causes of newborn respiratory insufficiency. 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引用次数: 0
摘要
导语：气泡CPAP （bCPAP）对早产儿呼吸窘迫综合征及其他原因引起的新生儿呼吸功能不全的治疗非常有效。为了克服bCPAP使用的障碍，开发了一种可清洁、消毒和重复使用的新型系统。本研究评估了使用再加工bCPAP系统是否会增加新生儿败血症的发生率。方法：对一项单中心随机对照试验进行事后分析。NCT06082674)将机械呼吸机驱动的CPAP设备（MV-CPAP）与每次使用后清洗和消毒的可重复使用bCPAP系统进行了比较。主要结局是治疗升级或死亡的综合结果。结果：75名新生儿随机分为两个CPAP治疗组。死亡（5 vs. 4）、护理升级（10 vs. 9）和综合结局(OR = 0.84；95% CI: 0.30-2.35, p = 0.743)。在任何次要结局方面均无临床显著差异。讨论：使用旨在增加全球CPAP可及性的再加工bCPAP系统并未增加新生儿败血症的发生率。临床试验注册：ClinicalTrials.gov，识别码，（NCT06082674）。
Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial.
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.
期刊介绍：
Frontiers in Pediatrics (Impact Factor 2.33) publishes rigorously peer-reviewed research broadly across the field, from basic to clinical research that meets ongoing challenges in pediatric patient care and child health. Field Chief Editors Arjan Te Pas at Leiden University and Michael L. Moritz at the Children''s Hospital of Pittsburgh are supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
Frontiers in Pediatrics also features Research Topics, Frontiers special theme-focused issues managed by Guest Associate Editors, addressing important areas in pediatrics. In this fashion, Frontiers serves as an outlet to publish the broadest aspects of pediatrics in both basic and clinical research, including high-quality reviews, case reports, editorials and commentaries related to all aspects of pediatrics.
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