Cerebral Oximetry Monitoring in Extremely Preterm Infants

Mathias L. Hansen; Adelina Pellicer; Simon Hyttel-Sørensen; Ebru Ergenekon; Tomasz Szczapa; Cornelia Hagmann; Gunnar Naulaers; Jonathan Mintzer; Monica Fumagalli; Gabriel Dimitriou; Eugene Dempsey; Jakub Tkaczyk; Guoqiang Cheng; Siv Fredly; Anne M. Heuchan; Gerhard Pichler; Hans Fuchs; Saudamini Nesargi; Gitte H. Hahn; Salvador Piris-Borregas; Jan Širc; Miguel Alsina-Casanova; Martin Stocker; Hilal Ozkan; Kosmas Sarafidis; Andrew O. Hopper; Tanja Karen; Beata Rzepecka-Weglarz; Serife S. Oguz; Luis Arruza; Asli C. Memisoglu; Ruth Del Rio Florentino; Mariana Baserga; Pierre Maton; Anita C. Truttmann; Isabel De Las Cuevas; Peter Agergaard; Pamela Zafra; Lars Bender; Ryszard Lauterbach; Chantal Lecart; Julie De Buyst; Afif El-Khuffash; Anna Curley; Olalla O. Vaccarello; Jan Miletin; Evangelia Papathoma; Zachary Vesoulis; Giovanni Vento; Luc Cornette; Laura S. Lopez; Beril Yasa; Anja Klamer; Massimo Agosti; Olivier Baud; Emmanuele Mastretta; Merih Cetinkaya; Karen McCall; Shujuan Zeng; Eleftheria Hatzidaki; Agata Bargiel; Sylwia Marciniak; Xiaoyan Gao; Lin Huijia; Lina Chalak; Ling Yang; Shashidhar A. Rao; Xin Xu; Begoña L. Gonzalez; Maria Wilinska; Zhaoqing Yin; Iwona Sadowska-Krawczenko; Itziar Serrano-Viñuales; Barbara Krolak-Olejnik; Marta M. Ybarra; Catalina Morales-Betancourt; Peter Korček; Marta Teresa-Palacio; Fabio Mosca; Anja Hergenhan; Nilgun Koksal; Konstantia Tsoni; Munaf M. Kadri; Claudia Knöpfli; Elzbieta Rafinska-Wazny; Mustafa S. Akin; Tone Nordvik; Zhang Peng; Sinem G. Kersin; Liesbeth Thewissen; Ana Alarcon; David Healy; Berndt Urlesberger; Münevver Baş; Jana Baumgartner; Eleni Skylogianni; Veronika Karadyova; Eva Valverde; Elena Bergon-Sendin; Jachym Kucera; Silvia Pisoni; Le Wang; Anne Smits; Rebeca Sanchez-Salmador; Marie I. Rasmussen; Markus H. Olsen; Aksel K. Jensen; Christian Gluud; Janus C. Jakobsen; Gorm Greisen

doi:10.1056/NEJMoa2207554

Cerebral Oximetry Monitoring in Extremely Preterm Infants

Mathias L. Hansen, Adelina Pellicer, Simon Hyttel-Sørensen, Ebru Ergenekon, Tomasz Szczapa, Cornelia Hagmann, Gunnar Naulaers, Jonathan Mintzer, Monica Fumagalli, Gabriel Dimitriou, Eugene Dempsey, Jakub Tkaczyk, Guoqiang Cheng, Siv Fredly, Anne M. Heuchan, Gerhard Pichler, Hans Fuchs, Saudamini Nesargi, Gitte H. Hahn, Salvador Piris-BorregasJan Širc, Miguel Alsina-Casanova, Martin Stocker, Hilal Ozkan, Kosmas Sarafidis, Andrew O. Hopper, Tanja Karen, Beata Rzepecka-Weglarz, Serife S. Oguz, Luis Arruza, Asli C. Memisoglu, Ruth Del Rio Florentino, Mariana Baserga, Pierre Maton, Anita C. Truttmann, Isabel De Las Cuevas, Peter Agergaard, Pamela Zafra, Lars Bender, Ryszard Lauterbach, Chantal Lecart, Julie De Buyst, Afif El-Khuffash, Anna Curley, Olalla O. Vaccarello, Jan Miletin, Evangelia Papathoma, Zachary Vesoulis, Giovanni Vento, Luc Cornette, Laura S. Lopez, Beril Yasa, Anja Klamer, Massimo Agosti, Olivier Baud, Emmanuele Mastretta, Merih Cetinkaya, Karen McCall, Shujuan Zeng, Eleftheria Hatzidaki, Agata Bargiel, Sylwia Marciniak, Xiaoyan Gao, Lin Huijia, Lina Chalak, Ling Yang, Shashidhar A. Rao, Xin Xu, Begoña L. Gonzalez, Maria Wilinska, Zhaoqing Yin, Iwona Sadowska-Krawczenko, Itziar Serrano-Viñuales, Barbara Krolak-Olejnik, Marta M. Ybarra, Catalina Morales-Betancourt, Peter Korček, Marta Teresa-Palacio, Fabio Mosca, Anja Hergenhan, Nilgun Koksal, Konstantia Tsoni, Munaf M. Kadri, Claudia Knöpfli, Elzbieta Rafinska-Wazny, Mustafa S. Akin, Tone Nordvik, Zhang Peng, Sinem G. Kersin, Liesbeth Thewissen, Ana Alarcon, David Healy, Berndt Urlesberger, Münevver Baş, Jana Baumgartner, Eleni Skylogianni, Veronika Karadyova, Eva Valverde, Elena Bergon-Sendin, Jachym Kucera, Silvia Pisoni, Le Wang, Anne Smits, Rebeca Sanchez-Salmador, Marie I. Rasmussen, Markus H. Olsen, Aksel K. Jensen, Christian Gluud, Janus C. Jakobsen, Gorm Greisen

Research output: Contribution to journal › Article › peer-review

17 Scopus citations

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.).

Original language	English (US)
Pages (from-to)	1501-1511
Number of pages	11
Journal	New England Journal of Medicine
Volume	388
Issue number	16
DOIs	https://doi.org/10.1056/NEJMoa2207554
State	Published - 2023

Keywords

Complications of Pregnancy
Neonatology
Obstetrics/Gynecology
Pediatrics

ASJC Scopus subject areas

General Medicine

Access to Document

10.1056/NEJMoa2207554

Cite this

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/NEJMoa2207554

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/NEJMoa2207554

@article{082cb8f2530c480281384fb582731b78,

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 = "Funding Information: Supported by the Capital Region of Denmark; grants from the Elsass Foundation , the Svend Andersen Foundation , and the Aage and Johanne Louis-Hansen Foundation ; and financial and technological contributions from businesses and institutions in the trial-center countries (Table S13 in the ). Publisher Copyright: {\textcopyright} 2023 Massachusetts Medical Society.",

year = "2023",

doi = "10.1056/NEJMoa2207554",

language = "English (US)",

volume = "388",

pages = "1501--1511",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "16",

}

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 - Funding Information: Supported by the Capital Region of Denmark; grants from the Elsass Foundation , the Svend Andersen Foundation , and the Aage and Johanne Louis-Hansen Foundation ; and financial and technological contributions from businesses and institutions in the trial-center countries (Table S13 in the ). 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

UR - http://www.scopus.com/inward/record.url?scp=85159568625&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85159568625&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2207554

DO - 10.1056/NEJMoa2207554

M3 - Article

C2 - 37075142

AN - SCOPUS:85159568625

SN - 0028-4793

VL - 388

SP - 1501

EP - 1511

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 16

ER -

Cerebral Oximetry Monitoring in Extremely Preterm Infants

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this