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. (24th January 2023)

• Record Type: Journal Article
• Authors: Pichler, Gerhard; Goeral, Katharina; Hammerl, Marlene; Perme, Tina; Dempsey, Eugene M; Springer, Laila; Lista, Gianluca; Szczapa, Tomasz; Fuchs, Hans; Karpinski, Lukasz; Bua, Jenny; Avian, Alexander; Law, Brenda; Urlesberger, Berndt; Buchmayer, Julia; Kiechl-Kohlendorfer, Ursula; Kornhauser-Cerar, Lilijana; Schwarz, Christoph E; Gründler, Kerstin; Stucchi, Ilaria; Schwaberger, Bernhard; Klebermass-Schrehof, Katrin; Schmölzer, Georg M
• Other Names: author non-byline.; Wolfsberger Christina author non-byline.; Baik-Schneditz Nariae author non-byline.; Bruckner Marlies author non-byline.; Binder-Heschl Corinna author non-byline.; Pfurtscheller Daniel author non-byline.; Martensen Johann author non-byline.; Höller Nina author non-byline.; Ziehenberger Evelyn author non-byline.; Berger Angelika author non-byline.; Baumgartner Sigrid author non-byline.; Grill Agnes author non-byline.; Mayr Michaela author non-byline.; Rittenschober-Boehm Judith author non-byline.; Schneider Michael author non-byline.; Schreiner Christina author non-byline.; Griesmaier Elke author non-byline.; Neubauer Vera author non-byline.; Wöckinger Peter author non-byline.; Posod Anna author non-byline.; Marolt Anja author non-byline.; Dimnik Ana author non-byline.; Lubej Kurtovič Vlasta author non-byline.; Aisling Garvey author non-byline.; Panaviene Jurate author non-byline.; Healy David author non-byline.; Ahmed Nahla author non-byline.; Herlihy Ita author non-byline.; Franz Axel author non-byline.; Castoldi Francesca author non-byline.; Cavigioli Francesco author non-byline.; Kozłowska Zuzanna author non-byline.; Minta Marcin author non-byline.; Owsiańska Zuzanna author non-byline.; Kahtan Sonia author non-byline.; Neumann-Klimasińska Natalia author non-byline.; Wróbel Karolina author non-byline.; Kubiaczyk Agata author non-byline.; Kosik Katarzyna author non-byline.; Olek Katarzyna author non-byline.; Bugiera Michalina author non-byline.; Porwolik Julita author non-byline.; Basiukajć Agnieszka author non-byline.; Czapla Elzbieta author non-byline.; Łukaszuk Wojciech author non-byline.; Gryczka Katarzyna author non-byline.; Naskręcka Dobrochna author non-byline.; Mazela Jan author non-byline.; Szymankiewicz-Bręborowicz Marta author non-byline.; Klotz Daniel author non-byline.; Baumgartner Jana author non-byline.; Bembich Stefano author non-byline.; Travan Laura author non-byline.; Cheung Po-Yin author non-byline.;
• Is Part Of: BMJ. Volume 380(2023)
• Publication Date: 2023-01-24
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj-2022-072313
• Languages: English
• ISSNs: 0007-1447

Abstract

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 .