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
From the Departments of Neonatology (M.L.H., G.H.H., M.I.S.R., G.G.) and Intensive Care (S.H.-S.), Copenhagen Trial Unit, Center for Clinical Intervention Research, the Capital Region (M.H.O., C.G., J.C.J.), and the Department of Neuroanesthesiology, Neuroscience Center (M.H.O.), Copenhagen University Hospital-Rigshospitalet, and the Section of Biostatistics, Department of Public Health, University of Copenhagen (A.K.G.J.), Copenhagen, the Neonatal Intensive Care Unit, Aarhus University Hospital, Aarhus (P.A.), the Department of Neonatology, Aalborg University Hospital, Aalborg (L.B.), and the Department of Pediatrics, Odense University Hospital (A.K.), and the Department of Regional Health Research, the Faculty of Health Sciences, University of Southern Denmark (C.G., J.C.J.), Odense - all in Denmark; the Department of Neonatology, La Paz University Hospital (A.P., M.M.Y., E.V., R.S.-S.), the Neonatology Department, 12 de Octubre University Hospital (S.P.-B., C.M.-B., E.B.-S.), the Department of Neonatology, Instituto del Nino y del Adolescente, Hospital Clinico San Carlos-Instituto de Investigación Sanitaria San Carlos (L.A.), Madrid, the Department of Neonatology, Hospital Clínic Barcelona, BCNatal-Barcelona Center for Maternal-Fetal and Neonatal Medicine (M.A.-C., M.T.-P.), and the Department of Neonatology, Hospital Sant Joan de Deu (R.R.F., A.A.), Barcelona, the Neonatal Unit, Marqués de Valdecilla University Hospital, and the Department of Medical and Surgical Sciences, Cantabria University, Santander (I.C.), the Neonatal Intensive Care Unit, Puerta del Mar University Hospital, Cádiz (P.Z.), the Department of Neonatology, Hospital Universitario de Tarragona Juan XXIII, Tarragona (O.O.V.), the Neonatal Unit, University Hospital Virgen de las Nieves, Granada (L.S.L.), the Division of Neonatology, University Hospital Cruces, Biocruces Health Research Institute, Barakaldo (B.L.G.), and the Neonatology Division, Miguel Servet University Hospital, Zaragoza (I.S.-V.) - all in Spain; the Division of Newborn Medicine, Gazi University Hospital (E.E., M. Baş), and the Department of Neonatology, NICU, University of Health Sciences, Ankara City Hospital (S.S.O., M.S.A.), Ankara, the Department of Neonatology, Bursa Uludag University Faculty of Medicine, Bursa (H.O., N.K.), the Division of Neonatology, Department of Pediatrics, Marmara University Research and Education Hospital, Marmara University, School of Medicine (A.C.M., S.G.K.), and the Department of Neonatology, Kanuni Sultan Suleyman Training and Research Hospital (B.Y., M.C.), Istanbul, and Basaksehir Cam and Sakura City Hospital, Basaksehir (B.Y., M.C.) - all in Turkey; the 2nd Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan (T.S.), the Department of Neonatology, Centrum Medyczne Ujastek (B.R.-W., E.R.-W.), and the Department of Neonatology, Jagiellonian University Hospital (R.L.), Krakow, Warsaw University of Medical Sciences (A.B.) and the Neonatology Department, Center of Postgraduate Medical Education (M.W.), Warsaw, the Neonatal Unit, Specialist Hospital No. 2, Bytom (S.M.), the Department of Neonatology, Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Torun, Bydgoszcz (I.S.-K.), and the Department of Neonatology, Wroclaw Medical University, Wroclaw (B.K.-O.) - all in Poland; Pediatric Intensive Care and Neonatology, Children's University Hospital of Zurich (C.H.), and the Department of Neonatology, University Hospital Zurich (T.K., C.K.), Zurich, the Intensive Care Unit, Children's Hospital Lucerne, Lucerne (M.S., A.H.), the Clinic of Neonatology, Department of Women, Mother and Child, University Hospital Center, and the University of Lausanne, Lausanne (A.C.T.), and the Division of Neonatology and Pediatric Intensive Care, Children's University Hospital of Geneva, and University of Geneva, Geneva (O.B.) - all in Switzerland; the Department of Development and Regeneration Katholieke Universiteit Leuven, Leuven (G.N., L.T., A.S.), Service de Néonatologie, Clinique Centre Hospitalier Chrétien Montlégia-Liège-Belgium, Liege (P.M.), the Department of Neonatology, Grand Hôpital de Charleroi, Charleroi (C.L.), NICU, Tivoli Hospital, La Louviere (J. Buyst), and the Department of Neonatology, Algemeen Ziekenhuis St.-Jan Bruges, Bruges (L. Cornette) - all in Belgium; the Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ (J. Mintzer); Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (M.F., F.M., S.P.), the Department of Clinical Sciences and Community Health, University of Milan (M.F., F.M.), Milan, Unità Operativa Complessa di Neonatologia, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome (G.V.), the Department of Neonatology, Neonatal Intensive Care Unit and Pediatrics, Filippo Del Ponte Hospital, University of Insubria, Varese (M.A.), and Struttura Complessa Neonatologia, Osp. S.Anna-Città della Salute e della Scienza di Torino, Turin (E.M.) - all in Italy; NICU, Department of Pediatrics, Patras Medical School, Patras (G.D., E.S.), the 1st Department of Neonatology of Aristotle University of Thessaloniki, Ippokrateion General Hospital of Thessaloniki, Thessaloniki (K.S., K.T.), the Neonatal Intensive Care Unit, Alexandra University and State Maternity Hospital, Athens (E.P.), and the Department of Neonatology and NICU, University Hospital of Heraklion, Heraklion (E.H.) - all in Greece; the Infant Centre and Department of Paediatrics and Child Health, University College Cork, Cork (E.D., D.H.), and the School of Medicine, Department of Paediatrics, Royal College of Surgeons in Ireland (A.E.-K.), National Maternity Hospital (A.C.), Coombe Women and Infant University Hospital (J. Miletin), and Ireland University College Dublin (J. Miletin), Dublin - all in Ireland; the Department of Neonatology, University Hospital Motol (J.T., V.K.), and the Institute for the Care of Mother and Child (J.Š., J. Miletin, P.K., J.K.) and the Third Faculty of Medicine, Charles University (J.Š., P.K.), Prague - all in Czechia; the Department of Neonatology, Children's Hospital of Fudan University, Shanghai (G.C., Z.P., L.W.), the Department of Neonatology, Longgang District Central Hospital, Shenzen (S.Z.), the Department of Neonatology, Maternal and Child Health Hospital of Zhuang Autonomous Region, Quangxi (X.G.), the Department of Neonatal Intensive Care Unit, Children's Hospital of Zhejiang University School of Medicine, Hangzhou (L.H.), the Department of Neonatology, Hainan Women and Children's Medical Center, Haikou (L.Y.), the Department of Neonatology, Xiamen Children's Hospital, Xiamen (X.X.), and the Department of Neonatology, the People's Hospital of Dehong, Mangshi (Z.Y.) - all in China; the Department of Neonatology, Oslo University Hospital, Oslo (S.F., T.N.); the Department of Neonatal Medicine, Royal Hospital for Children, Glasgow (A.M.H.), and the Neonatology Department, University Hospital Wishaw, Wishaw (K.M.) - both in the United Kingdom; the Department of Pediatrics (G.P., B.U.) and the Research Unit for Neonatal Micro- and Macrocirculation (G.P.), Medical University of Graz, Graz, Austria; the Division of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescents Medicine, Medical Center-University of Freiburg, and the Faculty of Medicine, University of Freiburg, Freiburg, Germany (H.F., J. Baumgartner); the Department of Neonatology, St. John's Medical College, Bangalore, India (S.N., S.A.R.); the Division of Neonatology, Department of Pediatrics, Loma Linda University Children's Hospital, Loma Linda, CA (A.O.H., M.M.K.); the Division of Neonatology, University of Utah Hospital, Salt Lake City (M. Baserga); the Department of Pediatrics, Division of Newborn Medicine, Washington University School of Medicine, St. Louis (Z.V.); INSERM Unité 1141, University of Paris, Paris (O.B.); and the Division of Pediatrics-Neonatal-Perinatal, UT Southwestern, Dallas (L. Chalak).
N Engl J Med. 2023 Apr 20;388(16):1501-1511. doi: 10.1056/NEJMoa2207554.
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.
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.
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.
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.).
在极早产儿护理中，脑氧饱和度监测的应用正在增加。然而，缺乏其使用能改善临床结局的证据。
在这项于17个国家70个地点进行的随机3期试验中，我们将出生后6小时内的极早产儿（胎龄<28周）随机分组，一组在出生后的前72小时接受脑氧饱和度监测指导下的治疗，另一组接受常规护理。主要结局是在孕龄36周时死亡或脑超声检查显示严重脑损伤的复合结局。评估的严重不良事件包括死亡、严重脑损伤、支气管肺发育不良、早产儿视网膜病变、坏死性小肠结肠炎和晚发性败血症。
共有1601名婴儿接受随机分组，1579名（98.6%）接受了主要结局评估。在孕龄36周时，脑氧饱和度监测组772名婴儿中有272名（35.2%）发生死亡或严重脑损伤，而常规护理组807名婴儿中有274名（34.0%）发生（脑氧饱和度监测组相对风险为1.03；95%置信区间为0.90至1.18；P = 0.64）。两组严重不良事件的发生率无差异。
在极早产儿中，出生后前72小时接受脑氧饱和度监测指导的治疗与孕龄36周时死亡或严重脑损伤的发生率低于常规护理无关。（由埃尔萨斯基金会等资助；SafeBoosC-III临床试验注册号，NCT03770741。）
