Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial

Abstract

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 .

Oxygen in the neonatal ICU: a complicated history and where are we now?

“…They further concluded very little data exists and further studies are required with standardized approach for adequate comparison ( 139 ). A recent multinational, randomized controlled trial of over 600 preterm neonates demonstrated no difference in survival or cerebral injury when cerebral NIRS was measured in combination with defined treatment guidelines in the immediate resuscitation after birth ( 140 ).…”

The Critical Role of Technologies in Neonatal Care

“…NIRS use in neonatal care is currently limited and has traditionally been used as a research device. Two recent large multi-centre randomised controlled trials recruiting infants <32 weeks gestation comparing a cerebral NIRS monitoring protocol-driven management strategy soon after birth did not find any difference in death or brain injury compared to standard care [55,56]. A systematic review aiming to determine whether NIRS monitoring commenced before 6 h of age in infants with HIE could predict clinical outcomes found that there was very little standardised data present to draw any meaningful conclusions or to perform a metaanalysis [57].…”

Blood pressure and cerebral oxygenation with physiologically-based cord clamping: sub-study of the BabyDUCC trial

“…6,10 Continuous monitoring of regional cerebral tissue oxygen saturation (rStO 2 ) and fractional tissue oxygen extraction (cFTOE) using near-infrared spectroscopy (NIRS) has been performed during foetal-to-neonatal transition. 11,12 By measuring predominantly venous oxygen saturation, this technique enables an estimation of the balance between cerebral oxygen delivery and consumption. 10 Previous studies describing normal ranges of rStO 2 and cFTOE during fullterm neonatal transition have focused on infants with early cord clamping (ECC).…”