Cerebral oximetry monitoring in extremely preterm infants
Author
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
Cheng, Guoqiang
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
Hopper, Andrew O.
Karen, Tanja
Rzepecka-Weglarz, Beata
Oguz, Serife S.
Arruza, Luis
Memisoglu, Asli C.
del Rio Florentino, Ruth
Baserga, Mariana
Maton, Pierre
Truttmann, Anita C.
de las Cuevas, Isabel
Agergaard, Peter
Zafra, Pamela
Bender, Lars
Lauterbach, Ryszard
Lecart, Chantal
de Buyst, Julie
El-Khuffash, Afif
Curley, Anna
Vaccarello, Olalla O.
Miletin, Jan
Papathoma, Evangelia
Vesoulis, Zachary
Vento, Giovanni
Cornette, Luc
Lopez, Laura S.
Yasa, Beril
Klamer, Anja
Agosti, Massimo
Baud, Olivier
Mastretta, Emmanuele
Cetinkaya, Merih
McCall, Karen
Zeng, Shujuan
Hatzidaki, Eleftheria
Bargiel, Agata
Marciniak, Sylwia
Gao, Xiaoyan
Huijia, Lin
Chalak, Lina
Yang, Ling
Rao, Shashidhar A.
Xu, Xin
Gonzalez, Begoña L.
Wilinska, Maria
Yin, Zhaoqing
Sadowska-Krawczenko, Iwona
Serrano-Viñuales, Itziar
Krolak-Olejnik, Barbara
Ybarra, Marta M.
Morales-Betancourt, Catalina
Korček, Peter
Palacio, Marta Teresa
Mosca, Fabio
Hergenhan, Anja
Koksal, Nilgun
Tsoni, Konstantia
Kadri, Munaf M.
Knöpfli, Claudia
Rafinska-Wazny, Elzbieta
Akin, Mustafa S.
Nordvik, Tone
Peng, Zhang
Kersin, Sinem G.
Thewissen, Liesbeth
Alarcon, Ana
Healy, David
Urlesberger, Berndt
Baş, Münevver
Baumgartner, Jana
Skylogianni, Eleni
Karadyova, Veronika
Valverde, Eva
Bergon-Sendin, Elena
Kucera, Jachym
Pisoni, Silvia
Wang, Le
Smits, Anne
Sanchez-Salmador, Rebeca
Rasmussen, Marie I.
Olsen, Markus H.
Jensen, Aksel K.
Gluud, Christian
Jakobsen, Janus C.
Greisen, Gorm
Publication date
2023ISSN
0028-4793
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. opens in new tab.)
Document Type
Article
Document version
Published version
Language
English
Subject (CDU)
61 - Medical sciences
Keywords
Medicina
Medicine
Pages
10
Publisher
Massachusetts Medical Society
Collection
388
Is part of
The New England Journal of Medicine
Citation
Hansen, Mathias L.; Pellicer, Adelina; Hyttel-Sørensen, Simon [et al.]. Cerebral oximetry monitoring in extremely preterm infants. The New England Journal of Medicine, 2023, 388, p. 1501-1511. Disponible en: <https://www.nejm.org/doi/10.1056/NEJMoa2207554>. Fecha de acceso: 6 feb. 2024. DOI: 10.1056/NEJMoa2207554
This item appears in the following Collection(s)
- Ciències de la Salut [745]
Rights
© 2024 Massachusetts Medical Society