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氧气自动控制与手动控制以及极度早产婴儿的新生儿临床结果:一个多中心,并行组,随机,受控,优越性试验
Axel R Franz1, Christian A Maiwald2, Hendrik J Niemarkt3
1Department of Neonatology, University Children's Hospital Tübingen, Tübingen, Germany; Center for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Tübingen, Germany.
闭环自动控制吸入氧气 (FiO2-C) 没有改善极度早产婴儿的临床结果. 虽然在减少护理人员工作负担方面可能是安全的,但FiO2-C算法在广泛临床使用之前需要进一步测试.
科学领域:
- 新生儿重症监护室新生儿重症监护室
- 呼吸系统的支持呼吸系统的支持
- 临床试验中的临床试验.
背景情况:
- 极度早产的婴儿需要呼吸支,容易出现低血血症,这与严重的并发症有关.
- 高氧度和低氧症增加了早产婴儿的风险.
- 吸入氧气 (FiO2-C) 的闭环自动控制已经显示出稳定氧和 (SpO2) 和减少护理人员负担的潜力.
研究的目的:
- 评估与常规手动氧气控制相比,FiO2-C是否能改善极度早产婴儿的临床结果.
- 评估自动化FiO2控制在新生儿重症监护中的安全性和有效性.
主要方法:
- 一个多中心,随机控制的优越性试验,涉及1082名在月经后23至27周之间出生的婴儿.
- 婴儿被分配到FiO2-C或常规手动FiO2控制中.
- 主要终点是死亡,死性肠球炎,支气管肺功能障碍或早产严重视网膜病变的组合.
主要成果:
- 在FiO2-C组 (39%) 和常规手动对照组 (41%) 之间的初级复合终点没有显著差异 (调整后的几率比率为0.90,p=0.47).
- 在两组中都观察到类似的死亡率,死性肠球炎,支气管肺功能失调和早产严重视网膜病变.
- 没有发现与FiO2-C相关的危害证据,群体之间严重不良事件发生率相似.
结论:
- 在极度早产婴儿的新生儿临床结果中,FiO2-C并没有显示出改善.
- 长期使用FiO2-C可被认为是减少护理人员工作负担的安全措施.
- 在常规临床实施之前,FiO2-C算法需要严格的测试.
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