Медицинская библиотека · The New England journal of medicine · 2023

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

Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод в очереди

Аннотация

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.).

Для цитирования: 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.. The New England journal of medicine. 2023. DOI: 10.1056/nejmoa2207554.

Предметные рубрики MeSH

Humans Infant Infant, Newborn Brain Injuries Bronchopulmonary Dysplasia Cerebrovascular Circulation Infant, Extremely Premature Infant, Premature, Diseases Oximetry Cerebrum Ultrasonography Retinopathy of Prematurity Enterocolitis, Necrotizing Neonatal Sepsis

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