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Purpose <p>The SafeBoosC-III trial compared treatment guided by cerebral oximetry monitoring for the first 72&#xa0;h after birth with usual care in 1601 extremely preterm infants. Incidence of death or severe brain injury at 36&#xa0;weeks of postmenstrual age did not differ between the cerebral oximetry and usual care group (relative risk with cerebral oximetry, 1.03; 95% CI 0.90 to 1.18). To assess the probability of clinically important benefit or harm, we conducted secondary analyses in a Bayesian framework.</p> Methods <p>Primary analyses used a weakly informative prior assuming a wide range of effects, to assess the probability that treatment guided by cerebral oximetry monitoring carried an a priori defined clinically important benefit or harm (a relative risk below 0.90 or above 1.10) or any benefit or harm (a relative risk differing from 1.0) for death or severe brain injury. Secondary analyses used an evidence-based prior derived from relevant prior trials.</p> Results <p>Posterior probabilities of clinically important benefit or harm were 1.5% and 19.2%, respectively. Posterior probabilities of any benefit or harm were 28.7% and 71.3%, respectively. Probabilities derived from secondary analyses using evidence-based priors were consistent with those from the primary analysis.</p> Conclusion <p>Treatment guided by cerebral oximetry monitoring during the first 72&#xa0;h after birth in extremely preterm infants resulted in posterior probabilities of 1.5% for a clinically important benefit and 19.2% for a clinically important harm with respect to the incidence of death or severe brain injury at 36&#xa0;weeks of postmenstrual age.</p> Trial registration <p>ClinicalTrials.gov NCT03770741. Registered on 12 July 2018.</p>

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Treatment guided by cerebral oximetry monitoring in extremely preterm infants: a Bayesian analysis of the SafeBoosC-III randomised clinical trial

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  • 发表日期：

    2026年4月29日

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  • Mathias Lühr Hansen,
  • Markus Harboe Olsen,
  • Theis Lange,
  • Christian Gluud,
  • Tobias Haugegaard,
  • Robin Christensen,
  • Lehana Thabane,
  • Gorm Greisen,
  • Janus Christian Jakobsen,
  • Adelina Pellicer,
  • Afif El-Kuffash,
  • Agata Bargiel,
  • Ana Alarcon,
  • Andrew Hopper,
  • Anita Truttmann,
  • Anja Hergenhan,
  • Anja Klamer,
  • Anna Curley,
  • Anne Marie Heuchan,
  • Anne Smits,
  • Asli Cinar Memisoglu,
  • Barbara Krolak-Olejnik,
  • Beata Rzepecka,
  • Begona Loureiro Gonzales,
  • Beril Yasa,
  • Berndt Urlesberger,
  • Catalina Morales-Betancourt,
  • Chantal Lecart,
  • Claudia Knöepfli,
  • Cornelia Hagmann,
  • David Healy,
  • Ebru Ergenekon,
  • Eleftheria Hatzidaki,
  • Elena Bergon-Sendin,
  • Eleni Skylogianni,
  • Elzbieta Rafinska-Wazny,
  • Emmanuele Mastretta,
  • Eugene Dempsey,
  • Eva Valverde,
  • Evangelina Papathoma,
  • Fabio Mosca,
  • Gabriel Dimitriou,
  • Gerhard Pichler,
  • Giovanni Vento,
  • Gitte Holst Hahn,
  • Gunnar Naulaers,
  • Guoqiang Cheng,
  • Hans Fuchs,
  • Hilal Ozkan,
  • Isabel De Las Cuevas,
  • Itziar Serrano-Vinuales,
  • Iwona Sadowska-Krawczenko,
  • Jachym Kucera,
  • Jakub Tkaczyk,
  • Jan Miletin,
  • Jan Sirc,
  • Jana Baumgartner,
  • Jonathan Mintzer,
  • Julie De Buyst,
  • Karen McCall,
  • Konstantina Tsoni,
  • Kosmas Sarafidis,
  • Lars Bender,
  • Laura Serrano Lopez,
  • Le Wang,
  • Liesbeth Thewissen,
  • Lin Huijia,
  • Lina Chalak,
  • Ling Yang,
  • Luc Cornette,
  • Luis Arruza,
  • Maria Wilinska,
  • Mariana Baserga,
  • Marie Isabel Skov Rasmussen,
  • Marta Mencia Ybarra,
  • Marta Teresa Palacio,
  • Martin Stocker,
  • Massimo Agosti,
  • Merih Cetinkaya,
  • Miguel Alsina,
  • Monica Fumagalli,
  • Munaf M. Kadri,
  • Mustafa Senol Akin,
  • Münevver Baş,
  • Nilgun Koksal,
  • Olalla Otero Vaccarello,
  • Olivier Baud,
  • Pamela Zafra,
  • Peter Agergaard,
  • Peter Korcek,
  • Pierre Maton,
  • Rebeca Sanchez-Salmador,
  • Ruth del Rio Florentino,
  • Ryszard Lauterbach,
  • Salvador Piris Borregas,
  • Saudamini Nesargi,
  • Serife Suna Oguz,
  • Shashidhar Appaji Rao,
  • Shujuan Zeng,
  • Silvia Pisoni,
  • Simon Hyttel-Sørensen,
  • Sinem Gulcan Kersin,
  • Siv Fredly,
  • Sylvia Marciniak,
  • Tanja Karen,
  • Tomasz Szczapa,
  • Tone Nordvik,
  • Veronika Karadyova,
  • Xiaoyan Gao,
  • Xin Xu,
  • Zachary Vesoulis,
  • Zhang Peng,
  • Zhaoqing Yin

摘要

Purpose

The SafeBoosC-III trial compared treatment guided by cerebral oximetry monitoring for the first 72 h after birth with usual care in 1601 extremely preterm infants. Incidence of death or severe brain injury at 36 weeks of postmenstrual age did not differ between the cerebral oximetry and usual care group (relative risk with cerebral oximetry, 1.03; 95% CI 0.90 to 1.18). To assess the probability of clinically important benefit or harm, we conducted secondary analyses in a Bayesian framework.

Methods

Primary analyses used a weakly informative prior assuming a wide range of effects, to assess the probability that treatment guided by cerebral oximetry monitoring carried an a priori defined clinically important benefit or harm (a relative risk below 0.90 or above 1.10) or any benefit or harm (a relative risk differing from 1.0) for death or severe brain injury. Secondary analyses used an evidence-based prior derived from relevant prior trials.

Results

Posterior probabilities of clinically important benefit or harm were 1.5% and 19.2%, respectively. Posterior probabilities of any benefit or harm were 28.7% and 71.3%, respectively. Probabilities derived from secondary analyses using evidence-based priors were consistent with those from the primary analysis.

Conclusion

Treatment guided by cerebral oximetry monitoring during the first 72 h after birth in extremely preterm infants resulted in posterior probabilities of 1.5% for a clinically important benefit and 19.2% for a clinically important harm with respect to the incidence of death or severe brain injury at 36 weeks of postmenstrual age.

Trial registration

ClinicalTrials.gov NCT03770741. Registered on 12 July 2018.