Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial.
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Rasmussen Marie Isabel Skov, Hansen Mathias L, Pellicer Adelina, Hyttel-Sørensen Simon, Ergenekon Ebru, Szczapa Tomasz, Hagmann Cornelia, Naulaers Gunnar, Mintzer Jonathan, Fumagalli Monica, Dimitriou Gabriel, Dempsey Eugene, Tkaczyk Jakub, Fredly Siv, Heuchan Anne M, Pichler Gerhard, Fuchs Hans, Nesargi Saudamini, Hahn Gitte H, Piris-Borregas Salvador, Širc Jan, Alsina-Casanova Miguel, Stocker Martin, Ozkan Hilal, Sarafidis Kosmas, Kraus Nicole J, Karen Tanja, Rzepecka-Weglarz Beata, Oguz Serife S, Thewissen Liesbeth, Arruza Luis, Memisoglu Asli C, Del Rio Florentino Ruth, Baserga Mariana, Maton Pierre, Schneider Juliane, de Las Cuevas M Isabel, Hedegaard Sofie Sommer, Zafra Pamela, Bender Lars, Farquharson Sarah, Ochoda-Mazur Agnieszka, Lecart Chantal, El-Khuffash Afif, Chathasaigh Caitríona Ní, Miletin Jan, Papathoma Evangelia, Vesoulis Zachary, Serrao Francesca, SafeBoosC-III Follow-Up Writing Group for the SafeBoosC-III Follow-Up Collaborator Group, Cornette Luc, Yasa Beril, Klamer Anja, Barcos-Munoz Francisca, Boetti Tatiana, Cetinkaya Merih, Montasser Mahmoud, Hatzidaki Eleftheria, Bokiniec Renata, Marciniak Sylwia, Chalak Lina, Rao Shashidhar A, Sadowska-Krawczenko Iwona, Serrano-Viñuales Itziar, Krolak-Olejnik Barbara, Plomgaard Anne Mette, Hansen Bo Mølholm, Olsen Markus Harboe, Gluud Christian, Jakobsen Janus C, Greisen Gorm
Аннотация
OBJECTIVE: To determine whether treatment guided by cerebral oximetry monitoring during the first 72 hours after birth reduces the risk of death or longer-term neurodevelopmental outcomes at 2 years' corrected age, compared with usual care.
DESIGN, SETTING, AND PARTICIPANTS: In the phase 3 Safeguarding the Brain of Our Smallest Children (SafeBoosC-III) randomized clinical trial, we compared treatment guided by cerebral oximetry monitoring with usual care for the first 72 hours after birth. Seventy sites across 17 countries randomized 1601 infants within 6 hours of birth. Infants from 56 sites participated in this follow-up. Blinded assessors evaluated outcomes using a predefined 3-tier data model combining formal clinical assessments, parental questionnaires, and informal assessments. Data were analyzed from October to December 2024.
INTERVENTIONS: Treatment guided by cerebral oximetry monitoring for the first 72 hours after birth vs usual care.
MAIN OUTCOMES AND MEASURES: The coprimary outcomes were as follows: (1) death or moderate or severe neurodevelopmental disability and (2) Bayley cognitive composite score, both assessed at approximately 2 years' corrected age.
RESULTS: A total of 1438 infants (mean [SD] age, 26.0 [1.3] weeks; 758 male [52.7%]) participated in this follow-up study. Participants were followed up from October 2021 to October 2024. Death or moderate or severe neurodevelopmental disability occurred in 292 of 620 infants (47.1%) in the cerebral oximetry group compared with 321 of 669 infants (48.0%) in the usual-care group (relative risk with cerebral oximetry, 0.96; 97.5% CI, 0.85-1.07; P = .45). The mean (SD) Bayley cognitive score was 92.8 (17.0) in the cerebral oximetry group compared with 93.2 (17.3) in the usual-care group (mean difference with cerebral oximetry, -0.14; 97.5% CI, -3.24 to 2.96; P = .92).
CONCLUSIONS AND RELEVANCE: In extremely preterm infants, treatment guided by cerebral oximetry monitoring compared with usual care for the first 72 hours after birth did not result in a lower incidence of death or moderate or severe neurodevelopmental disability nor higher Bayley cognitive scores at 2 years' corrected age. The routine use of cerebral oximetry monitoring during the first 72 hours after birth in extremely preterm infants to reduce neurodevelopmental disability was not supported by this trial.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05134116.