Hansen ML, Pellicer A, Hyttel-Sørensen S, Ergenekon E, Szczapa T, Hagmann C, Naulaers G, Mintzer J, Fumagalli M, Dimitriou G, Dempsey E, Tkaczyk J, Cheng G, Fredly S, Heuchan AM, Pichler G, Fuchs H, Nesargi S, Hahn GH, Piris-Borregas S, Širc J, Alsina-Casanova M, Stocker M, Ozkan H, Sarafidis K, Hopper AO, Karen T, Rzepecka-Weglarz B, Oguz SS, Arruza L, Memisoglu AC, Del Rio Florentino R, Baserga M, Maton P, Truttmann AC, de Las Cuevas I, Agergaard P, Zafra P, Bender L, Lauterbach R, Lecart C, de Buyst J, El-Khuffash A, Curley A, Vaccarello OO, Miletin J, Papathoma E, Vesoulis Z, Vento G, Cornette L, Lopez LS, Yasa B, Klamer A, Agosti M, Baud O, Mastretta E, Cetinkaya M, McCall K, Zeng S, Hatzidaki E, Bargiel A, Marciniak S, Gao X, Huijia L, Chalak L, Yang L, Rao SA, Xu X, Gonzalez BL, Wilinska M, Yin Z, Sadowska-Krawczenko I, Serrano-Viñuales I, Krolak-Olejnik B, Ybarra MM, Morales-Betancourt C, Korček P, Teresa-Palacio M, Mosca F, Hergenhan A, Koksal N, Tsoni K, Kadri MM, Knöpfli C, Rafinska-Wazny E, Akin MS, Nordvik T, Peng Z, Kersin SG, Thewissen L, Alarcon A, Healy D, Urlesberger B, Baş M, Baumgartner J, Skylogianni E, Karadyova V, Valverde E, Bergon-Sendin E, Kucera J, Pisoni S, Wang L, Smits A, Sanchez-Salmador R, Rasmussen MI, Olsen MH, Jensen AK, Gluud C, Jakobsen JC, and Greisen G
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.)., (Copyright © 2023 Massachusetts Medical Society.)