Cerebral Oximetry in Extremely Preterm Infants

Importance: Cerebral oximetry monitoring in the first 72 hours after birth has not been shown to reduce death or severe brain injury at 36 weeks' postmenstrual age in extremely preterm infants. The long-term effects remain uncertain. 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.

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Journal
JAMA Pediatrics
Published
2026-04-20
DOI
https://doi.org/10.1001/jamapediatrics.2026.1066
Primary Topic
Neonatal and fetal brain pathology
Type
article
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article

Cerebral Oximetry in Extremely Preterm Infants

Chantal Lecart, Mariana Baserga, Amanda Duncan, J Miletin et al.
JAMA Pediatrics
Neonatal and fetal brain pathology
article

Cerebral Oximetry in Extremely Preterm Infants

Chantal Lecart, Mariana Baserga, Amanda Duncan, J Miletin, Gülsüm Kadıoğlu, Martin Stocker, Pamela Zafra, Rosa Ayesa‐Arriola, Justyna Fiałkowska, Trisha Marchant, Ruth del Rio Florentino, Luis Arruza, Miguel Alsina Casanova, Sofie Sommer Hedegaard, Sarah Farquharson, Claudia Knöpfli, Salvador Piris‐Borregas, Jonathan Mintzer, Liesbeth Thewissen, Nancy Laval, Caitríona Ní Chathasaigh, Isabel Cuéllar‐Flores, Jan Širc, Ebru Ergenekon, Agnieszka Ochoda, Camilla Fontana, AM Heuchan, Lars Bender, Elżbieta Rafińska‐Ważny, Luc Cornette, Beata Rzepecka-Węglarz, Saudamini Nesargi, Isabel Benavente‐Fernández, Pierre Maton, Siv Fredly, Nicole J. Kraus, Elisabeth Pichler-Stachl, Jakub Tkaczyk, Beril Yaşa, Halime Sema Can Buker, Marta Teresa‐Palacio, Sinem Gülcan Kersin, Cristina Borradori Tolsa, Hilal Özkan, E. Papathoma, Francesca Serrao, Aikaterini Nourloglou, Katarína Tichá, Iga Rupniak, Thais Agut Quijano, Şebnem Soysal, Milenka Cuevas, Tanja Karen, Iyshwarya Stapleton, Cornelia Hagmann, Jyothsna Purna, Alexander Scheid, Els Ortibus, Adelina Pellicer, Zachary Vesoulis, Afif El-Khuffash, Asli C. Memisoglu, Mathias L. Hansen, Gerhard Pichler, Tomasz Szczapa, Roksana Malak, Gitte H. Hahn, Malaika Cordeiro Alcaine, Gabriel Dimitriou, Hans Fuchs, Monica Fumagalli, Katelyn Hoffer, Juliane Schneider, Anna Oostra, Serife S. Oguz, Paulina Gaweł, Anja Klamer, Mustafa Bostanci, Zuzana Matějková, Nicole Hilda Anagnostatou, Anjali Raj, Simon Hyttel-Sørensen, Ani Majeed, Barbara Imboden, Jsun Wong, Myriam Bickle Graz, Eugene Dempsey, Kasia Szczepanska, SafeBoosC-III Follow-Up Writing Group for the SafeBoosC-III Follow-Up Collaborator Group, Pilar Abenia, Anna Zoraide Patria, Gunnar Naulaers, Vasiliki Kourou, Kosmas Sarafidis, Marie-Julie Debuf, Tone Nordvik, Maria Palomares Eraso, Marie Isabel Skov Rasmussen
article en

Abstract

Importance: Cerebral oximetry monitoring in the first 72 hours after birth has not been shown to reduce death or severe brain injury at 36 weeks' postmenstrual age in extremely preterm infants. The long-term effects remain uncertain. 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.

JAMA Pediatrics
University College Dublin (IE), Poznan University of Medical Sciences (PL), Jagiellonian University (PL), Oslo University Hospital (NO), Hospital Sant Joan de Déu Barcelona (ES), Bursa Uludağ Üni̇versi̇tesi̇ (TR), Royal College of Surgeons in Ireland (IE), Ankara University (TR), University of Freiburg (DE), University of Lucerne (CH), University of Health Science (KH), University of Patras (GR), University of Milan (IT), Medical University of Graz (AT), Washington University in St. Louis (US), Charles University (CZ), Aristotle University of Thessaloniki (GR), Meta (Israel) (IL), University College Cork (IE), Aalborg University Hospital (DK), Royal Hospital for Children (GB), Hackensack University Medical Center Mountainside (US), Hospital Universitario La Paz (ES), University Medical Center Freiburg (DE), Odense University Hospital (DK), Glostrup Hospital (DK), Agostino Gemelli University Polyclinic (IT), Copenhagen University Hospital (DK), Rigshospitalet (DK), University of Utah Hospital (US), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Hospital Clínico San Carlos (ES), Centre Hospitalier Chrétien (BE), Research Institute Hospital 12 de Octubre (ES), Coombe Women & Infants University Hospital (IE), Eskişehir City Hospital (TR), Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (ES), University Hospital in Motol (CZ), Memorial Ankara Hospital (TR), Biogipuzkoa Health Research Institute (ES), University Hospital of Zurich (CH), Infant (IE), Hospital La Paz Institute for Health Research (ES), University of Teacher Education Lucerne (CH), Alexandra Hospital (GR), Hospital Clínic de Barcelona (ES), Ippokrateio General Hospital of Thessaloniki (GR), Centrum Medyczne iMed24 (PL), AZ Sint-Jan (BE), Mother Hospital (IN), Sağlık Bilimleri Üniversitesi (TR), University Children's Hospital Zurich (CH), National Maternity Hospital (IE), Medicina (PL), Ústav pro Péči o Matku a Dítě (CZ), Hospital Universitario Puerta del Mar (ES), St.John's Medical College Hospital (IN), Grand Charleroi Hospital (BE), İstanbul Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi (TR), Loma Linda University Children's Hospital (US), Marmara University (TR), Lucerne University of Applied Sciences and Arts (CH), University of Health Sciences Antigua (AG), Gazi University (TR), University of Lausanne (CH), KU Leuven (BE)
Univerzita Karlova v Praze, Loma Linda University, Uniwersytet Jagielloński Collegium Medicum, Università degli Studi di Milano, Royal College of Surgeons in Ireland, Bursa Uludağ Üniversitesi, University College Dublin, University College Cork, Aalborg Universitet, Albert-Ludwigs-Universität Freiburg, Gentofte Hospital, Gazi Üniversitesi, KU Leuven, Rigshospitalet, Aalborg Universitetshospital, Université de Lausanne, Aristotle University of Thessaloniki, Marmara Üniversitesi, Karl-Franzens-Universität Graz, Universitätsspital Zürich, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Medizinische Universität Graz, Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Medizinische Fakultät der Albert-Ludwigs-Universität Freiburg
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Neonatal and fetal brain pathology
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