Standard
Cerebral Oximetry Monitoring in Extremely Preterm Infants. / 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; Teresa-Palacio, Marta; 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.
In:
New England Journal of Medicine, Vol. 388, No. 16, 2023, p. 1501-1511.
Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
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
& Greisen, G 2023, '
Cerebral Oximetry Monitoring in Extremely Preterm Infants',
New England Journal of Medicine, vol. 388, no. 16, pp. 1501-1511.
https://doi.org/10.1056/NEJMoa2207554APA
Hansen, M. L., 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, A. M., Pichler, G., Fuchs, H., Nesargi, S., Hahn, G. H.
, ... Greisen, G. (2023).
Cerebral Oximetry Monitoring in Extremely Preterm Infants.
New England Journal of Medicine,
388(16), 1501-1511.
https://doi.org/10.1056/NEJMoa2207554Vancouver
Hansen ML, Pellicer A, Hyttel-Sørensen S, Ergenekon E, Szczapa T, Hagmann C et al.
Cerebral Oximetry Monitoring in Extremely Preterm Infants.
New England Journal of Medicine. 2023;388(16):1501-1511.
https://doi.org/10.1056/NEJMoa2207554Author
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 ; Teresa-Palacio, Marta ; 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. / Cerebral Oximetry Monitoring in Extremely Preterm Infants. In: New England Journal of Medicine. 2023 ; Vol. 388, No. 16. pp. 1501-1511.
Bibtex
@article{f71cb549893e4a65a0938b56f4fde64b,
title = "Cerebral Oximetry Monitoring in Extremely Preterm Infants",
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.).",
keywords = "Complications of Pregnancy, Neonatology, Obstetrics/Gynecology, Pediatrics",
author = "Hansen, {Mathias L.} and Adelina Pellicer and Simon Hyttel-S{\o}rensen and Ebru Ergenekon and Tomasz Szczapa and Cornelia Hagmann and Gunnar Naulaers and Jonathan Mintzer and Monica Fumagalli and Gabriel Dimitriou and Eugene Dempsey and Jakub Tkaczyk and Guoqiang Cheng and Siv Fredly and Heuchan, {Anne M.} and Gerhard Pichler and Hans Fuchs and Saudamini Nesargi and Hahn, {Gitte H.} and Salvador Piris-Borregas and Jan {\v S}irc and Miguel Alsina-Casanova and Martin Stocker and Hilal Ozkan and Kosmas Sarafidis and Hopper, {Andrew O.} and Tanja Karen and Beata Rzepecka-Weglarz and Oguz, {Serife S.} and Luis Arruza and Memisoglu, {Asli C.} and {Del Rio Florentino}, Ruth and Mariana Baserga and Pierre Maton and Truttmann, {Anita C.} and {De Las Cuevas}, Isabel and Peter Agergaard and Pamela Zafra and Lars Bender and Ryszard Lauterbach and Chantal Lecart and {De Buyst}, Julie and Afif El-Khuffash and Anna Curley and Vaccarello, {Olalla O.} and Jan Miletin and Evangelia Papathoma and Zachary Vesoulis and Giovanni Vento and Luc Cornette and Lopez, {Laura S.} and Beril Yasa and Anja Klamer and Massimo Agosti and Olivier Baud and Emmanuele Mastretta and Merih Cetinkaya and Karen McCall and Shujuan Zeng and Eleftheria Hatzidaki and Agata Bargiel and Sylwia Marciniak and Xiaoyan Gao and Lin Huijia and Lina Chalak and Ling Yang and Rao, {Shashidhar A.} and Xin Xu and Gonzalez, {Bego{\~n}a L.} and Maria Wilinska and Zhaoqing Yin and Iwona Sadowska-Krawczenko and Itziar Serrano-Vi{\~n}uales and Barbara Krolak-Olejnik and Ybarra, {Marta M.} and Catalina Morales-Betancourt and Peter Kor{\v c}ek and Marta Teresa-Palacio and Fabio Mosca and Anja Hergenhan and Nilgun Koksal and Konstantia Tsoni and Kadri, {Munaf M.} and Claudia Kn{\"o}pfli and Elzbieta Rafinska-Wazny and Akin, {Mustafa S.} and Tone Nordvik and Zhang Peng and Kersin, {Sinem G.} and Liesbeth Thewissen and Ana Alarcon and David Healy and Berndt Urlesberger and M{\"u}nevver Ba{\c s} and Jana Baumgartner and Eleni Skylogianni and Veronika Karadyova and Eva Valverde and Elena Bergon-Sendin and Jachym Kucera and Silvia Pisoni and Le Wang and Anne Smits and Rebeca Sanchez-Salmador and Rasmussen, {Marie I.} and Olsen, {Markus H.} and Jensen, {Aksel K.} and Christian Gluud and Jakobsen, {Janus C.} and Gorm Greisen",
note = "Publisher Copyright: {\textcopyright} 2023 Massachusetts Medical Society.",
year = "2023",
doi = "10.1056/NEJMoa2207554",
language = "English",
volume = "388",
pages = "1501--1511",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "16",
}
RIS
TY - JOUR
T1 - Cerebral Oximetry Monitoring in Extremely Preterm Infants
AU - Hansen, Mathias L.
AU - Pellicer, Adelina
AU - Hyttel-Sørensen, Simon
AU - Ergenekon, Ebru
AU - Szczapa, Tomasz
AU - Hagmann, Cornelia
AU - Naulaers, Gunnar
AU - Mintzer, Jonathan
AU - Fumagalli, Monica
AU - Dimitriou, Gabriel
AU - Dempsey, Eugene
AU - Tkaczyk, Jakub
AU - Cheng, Guoqiang
AU - Fredly, Siv
AU - Heuchan, Anne M.
AU - Pichler, Gerhard
AU - Fuchs, Hans
AU - Nesargi, Saudamini
AU - Hahn, Gitte H.
AU - Piris-Borregas, Salvador
AU - Širc, Jan
AU - Alsina-Casanova, Miguel
AU - Stocker, Martin
AU - Ozkan, Hilal
AU - Sarafidis, Kosmas
AU - Hopper, Andrew O.
AU - Karen, Tanja
AU - Rzepecka-Weglarz, Beata
AU - Oguz, Serife S.
AU - Arruza, Luis
AU - Memisoglu, Asli C.
AU - Del Rio Florentino, Ruth
AU - Baserga, Mariana
AU - Maton, Pierre
AU - Truttmann, Anita C.
AU - De Las Cuevas, Isabel
AU - Agergaard, Peter
AU - Zafra, Pamela
AU - Bender, Lars
AU - Lauterbach, Ryszard
AU - Lecart, Chantal
AU - De Buyst, Julie
AU - El-Khuffash, Afif
AU - Curley, Anna
AU - Vaccarello, Olalla O.
AU - Miletin, Jan
AU - Papathoma, Evangelia
AU - Vesoulis, Zachary
AU - Vento, Giovanni
AU - Cornette, Luc
AU - Lopez, Laura S.
AU - Yasa, Beril
AU - Klamer, Anja
AU - Agosti, Massimo
AU - Baud, Olivier
AU - Mastretta, Emmanuele
AU - Cetinkaya, Merih
AU - McCall, Karen
AU - Zeng, Shujuan
AU - Hatzidaki, Eleftheria
AU - Bargiel, Agata
AU - Marciniak, Sylwia
AU - Gao, Xiaoyan
AU - Huijia, Lin
AU - Chalak, Lina
AU - Yang, Ling
AU - Rao, Shashidhar A.
AU - Xu, Xin
AU - Gonzalez, Begoña L.
AU - Wilinska, Maria
AU - Yin, Zhaoqing
AU - Sadowska-Krawczenko, Iwona
AU - Serrano-Viñuales, Itziar
AU - Krolak-Olejnik, Barbara
AU - Ybarra, Marta M.
AU - Morales-Betancourt, Catalina
AU - Korček, Peter
AU - Teresa-Palacio, Marta
AU - Mosca, Fabio
AU - Hergenhan, Anja
AU - Koksal, Nilgun
AU - Tsoni, Konstantia
AU - Kadri, Munaf M.
AU - Knöpfli, Claudia
AU - Rafinska-Wazny, Elzbieta
AU - Akin, Mustafa S.
AU - Nordvik, Tone
AU - Peng, Zhang
AU - Kersin, Sinem G.
AU - Thewissen, Liesbeth
AU - Alarcon, Ana
AU - Healy, David
AU - Urlesberger, Berndt
AU - Baş, Münevver
AU - Baumgartner, Jana
AU - Skylogianni, Eleni
AU - Karadyova, Veronika
AU - Valverde, Eva
AU - Bergon-Sendin, Elena
AU - Kucera, Jachym
AU - Pisoni, Silvia
AU - Wang, Le
AU - Smits, Anne
AU - Sanchez-Salmador, Rebeca
AU - Rasmussen, Marie I.
AU - Olsen, Markus H.
AU - Jensen, Aksel K.
AU - Gluud, Christian
AU - Jakobsen, Janus C.
AU - Greisen, Gorm
N1 - Publisher Copyright:
© 2023 Massachusetts Medical Society.
PY - 2023
Y1 - 2023
N2 - 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.).
AB - 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.).
KW - Complications of Pregnancy
KW - Neonatology
KW - Obstetrics/Gynecology
KW - Pediatrics
U2 - 10.1056/NEJMoa2207554
DO - 10.1056/NEJMoa2207554
M3 - Journal article
C2 - 37075142
AN - SCOPUS:85159568625
VL - 388
SP - 1501
EP - 1511
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 16
ER -
