Objective To investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone. Design Multicentre, multinational, randomised controlled phase 3 trial. Setting 11 tertiary neonatal intensive care units in six countries in Europe and in Canada. Participants 1121 pregnant women (<32 weeks’ gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group. Intervention Preterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation. Main outcome measure The primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge. Results Cerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%) v control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70). Conclusion Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks’ gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant. Trial registration ClinicalTrials.gov [NCT03166722][1]. Deidentified data are available on request from the corresponding author (gerhard.pichler@medunigraz.at) on approval and with a signed data access agreement. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03166722&atom=%2Fbmj%2F380%2Fbmj-2022-072313.atom

中文翻译：

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脑区域组织氧饱和度指导早产儿在出生后立即过渡期间的氧输送（COSGOD III）：多中心随机第 3 期临床试验

目的 研究在立即过渡和复苏期间，除了常规监测外，使用近红外光谱监测脑组织氧饱和度，结合明确的治疗指南，与单独的标准护理相比，是否可以提高早产儿无脑损伤的生存率。设计多中心、多国、随机对照的 3 期试验。在欧洲和加拿大的六个国家设立 11 个三级新生儿重症监护病房。参与者 1121 名孕妇（<32 周妊娠）接受了产前筛查。主要结果在 655 名随机早产新生儿中的 607 名进行了分析：近红外光谱组 304 名新生儿和对照组 303 名新生儿。干预 早产新生儿在立即过渡（出生后 15 分钟）和复苏期间被随机分配到标准护理（对照组）或标准护理加监测脑氧饱和度的专门治疗指南（近红外光谱组）。主要结果测量 主要结果是使用全因死亡率和连续脑超声检查评估的，是无脑损伤生存的综合结果。脑损伤被定义为任何脑室内出血或囊性脑室周围白质软化，或两者兼而有之，在足月等效年龄或出院前。结果 两组脑组织氧饱和度相似。304 名新生儿中有 252 名 (82.9%)（中位孕龄 28.9（四分位间距 26.9-30。6) 周) 近红外光谱组在没有脑损伤的情况下存活，而对照组 303 名新生儿中有 238 名 (78.5%) (28.6 (26.6-30.6) 周) (相对风险 1.06，95% 置信区间 0.98 至 1.14) ). 28 名新生儿死亡（近红外光谱组 12 名（4.0%）vs 对照组 16 名（5.3%）：相对危险度 0.75（0.33 至 1.70）。结论 脑组织氧饱和度监测联合专门干预对早产儿（<32 周） ' 妊娠）在出生后立即过渡和复苏期间，与单独的标准护理相比，没有导致无脑损伤的存活率显着提高。无脑损伤的存活率增加了 4.3%，但没有统计学意义。试验注册 ClinicalTrials.gov [NCT03166722][1 ]. 经批准并签署数据访问协议后，可应相应作者 (gerhard.pichler@medunigraz.at) 的请求提供去标识化数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03166722&atom=%2Fbmj%2F380%2Fbmj-2022-072313.atom