针对性脑氧化使用专用治疗与极度早产婴儿的常规护理:多中心国际II期随机对照试验的协议
Pranav R Jani1,2, Traci-Anne Goyen1,2, Kiran Kumar Balegar Virupakshappa3,4
1Department of Neonatology, Westmead Hospital, Westmead, Australia.
Journal of paediatrics and child health
|April 21, 2025
概括
这项研究研究了使用近红外光谱 (NIRS) 在极度早产婴儿中向大脑氧化. 它的目的是保持稳定的大脑氧气水平,潜在地预防损伤,并为未来的神经发育研究提供信息.
科学领域:
- 新生儿医学 新生儿医学
- 临床试验 临床试验
- 医疗器械 医疗器械
背景情况:
- 近红外光谱 (NIRS) 能够持续监测大脑的氧化,这对于防止因氧气波动而引起的大脑损伤至关重要.
- 像Safe-BoosC-II这样的先前研究表明,在使用NIRS与多个设备的早产婴儿中,大脑氧化稳定.
- 在这个人群中,单个NIRS设备和专用算法的有效性在维持稳定的大脑氧化水平上仍未得到研究.
研究的目的:
- 评估在极度早产婴儿中保持稳定的大脑氧化能力,使用单个NIRS设备和新生儿传感器的专用治疗算法.
- 为了比较有针对性的脑氧化与预防缺氧和高氧的常规护理.
- 收集关于神经发育结果的未来随机对照试验 (RCT) 的数据.
主要方法:
- 一个多中心的,双臂的,单盲的,II期RCT,涉及100名怀孕29周以下的婴儿.
- 随机分配的参与者在生命的前5天接受了有针对性的脑氧化或通常的护理.
- 主要结局:大脑缺氧和高氧的负担 (百分比小时). 排除标准包括婴儿> 6小时,重大先天性异常或多胎 (三胎或更高).
主要成果:
- 这个部分不在所提供的摘要中.
结论:
- 调查结果将验证Safe-BoosC-II的结果,但方法上存在差异.
- 结果将支持大脑NIRS监测在极度早产婴儿的常规使用.
- 这项研究将为未来的RCT的设计提供信息,重点是针对性脑氧化对神经发育的影响.
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