Cerebral Oximetry Monitoring in Extremely Preterm Infants
Mathias Lühr Hansen, Adelina Pellicer, Simon Hyttel-Sørensen, Ebru Ergenekon, Tomasz Szczapa, Cornelia Hagmann, Gunnar Naulaers, Jonathan Mintzer, Monica Fumagalli, Gabriel Dimitriou, Eugene Dempsey, Jakub Tkaczyk, Guoqiang Cheng, Siv Fredly, Anne Marie Heuchan, Gerhard Pichler, Hans F. Fuchs, Saudamini Nesargi, Gitte Holst Hahn, Salvador Piris‐Borregas, Jan Širc, Miguel Alsina Casanova, Martin Stocker, Hilal Özkan, Kosmas Sarafidis, Andrew Hopper, Tanja Karen, Beata Rzepecka-Węglarz, Şerife Suna Oğuz, Luis Arruza, Aslı Memişoğlu, Ruth del Rio Florentino, Mariana Baserga, Pierre Maton, Anita C. Truttmann, Isabel de las Cuevas, Peter Agergaard, Pamela Zafra, Lars Bender, Ryszard Lauterbach, Chantal Lecart, Julie De Buyst, Afif El‐Khuffash, Anna Curley, Olalla Otero Vaccarello, Jan Miletín, E. Papathoma, Zachary A. Vesoulis, Giovanni Vento, Luc Cornette, Laura Serrano Lopez, Beril Yaşa, Anja Klamer, Massimo Agosti, Olivier Baud, Emmanuele Mastretta, Merih Çetınkaya, Karen McCall, Shujuan Zeng, Eleftheria Hatzidaki, Agata Bargiel, Sylwia Marciniak, Xiaoyan Gao, Lin Huijia, Lina F. Chalak, Ling Yang, Shashidhar A. Rao, Xin Xu, Begoña L. Gonzalez, Maria Wilińska, Zhaoqing Yin, Iwona Sadowska-Krawczenko, Itziar Serrano-Viñuales, Barbara Królak‐Olejnik, Marta Ybarra, Catalina Morales‐Betancourt, Peter Korček, Marta Teresa‐Palacio, Fabio Mosca, Anja Hergenhan, Nilgün Köksal, Konstantia Tsoni, Munaf M. Kadri, Claudia Knöpfli, Elżbieta Rafińska‐Ważny, Mustafa Şenol Akın, Tone Nordvik, Peng Zhang, Sinem G. Kersin, Liesbeth Thewissen, Ana Alarcón, David Healy, Berndt Urlesberger, Münevver Baş, Jana Baumgärtner, Eleni Skylogianni, Veronika Karadyova, Eva Valverde, Elena Bergón-Sendín, Jáchym Kučera
Abstract
BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).