Research Unit for Microcirculation and Macrocirculation of the Newborn, Medical University of Graz, Graz, Austria
Research Unit for Cerebral Development and Oximetry Research, Medical University of Graz, Graz, Austria.
BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.
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.
Multicentre, multinational, randomised controlled phase 3 trial.
11 tertiary neonatal intensive care units in six countries in Europe and in Canada.
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.
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.
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.
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%) control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70).
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.
ClinicalTrials.gov NCT03166722.
研究在即刻过渡期和复苏期间使用近红外光谱监测脑氧饱和度是否与单独使用常规监测结合明确的治疗指南相比，可增加无脑损伤的早产儿的存活率。
多中心、多国、随机对照 3 期试验。
欧洲和加拿大的 6 个国家的 11 个三级新生儿重症监护病房。
1121 名孕妇（<32 周妊娠）接受了产前筛查。对 655 名随机早产儿中的 607 名进行了主要结局分析：近红外光谱组 304 名，对照组 303 名。
早产儿被随机分配至标准护理（对照组）或标准护理加脑氧饱和度监测（近红外光谱组），并在即刻过渡期（出生后 15 分钟内）和复苏期间采用专门的治疗指南进行治疗。
主要结局通过全因死亡率和连续脑超声检查来评估，为无脑损伤的存活率的复合结局。脑损伤定义为在相当于足月的年龄或出院前任何脑室内出血或囊性脑室周围白质软化，或两者均有。
两组的脑氧饱和度相似。近红外光谱组 304 名（中位胎龄 28.9（四分位距 26.9-30.6）周）中 252 名（82.9%）早产儿无脑损伤存活，对照组 303 名（28.6（26.6-30.6）周）中 238 名（78.5%）存活（相对风险 1.06，95%置信区间 0.98-1.14）。28 名新生儿死亡（近红外光谱组 12 名[4.0%]；对照组 16 名[5.3%]：相对风险 0.75（0.33-1.70）。
与单独的标准护理相比，在早产儿（<32 周妊娠）的即刻过渡期和出生后复苏期间使用近红外光谱监测脑氧饱和度并结合专门干预措施，并未显著增加无脑损伤的存活率。无脑损伤的存活率增加了 4.3%，但无统计学意义。
ClinicalTrials.gov NCT03166722。
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