Cerebral Oximetry Monitoring in Extremely Preterm Infants

被引:54
作者
Hansen, Mathias L. [1 ]
Pellicer, Adelina [10 ]
Hyttel-Srensen, Simon [2 ]
Ergenekon, Ebru [22 ]
Szczapa, Tomasz [28 ]
Hagmann, Cornelia [36 ]
Naulaers, Gunnar [43 ]
Mintzer, Jonathan [48 ]
Fumagalli, Monica [49 ,50 ]
Dimitriou, Gabriel [54 ]
Dempsey, Eugene [60 ,61 ]
Tkaczyk, Jakub [66 ]
Cheng, Guoqiang [69 ]
Fredly, Siv [76 ]
Heuchan, Anne M. [77 ]
Pichler, Gerhard [79 ,80 ]
Fuchs, Hans [81 ]
Nesargi, Saudamini [82 ]
Hahn, Gitte H. [1 ]
Piris-Borregas, Salvador [11 ]
Sirc, Jan [67 ,68 ]
Alsina-Casanova, Miguel [13 ]
Stocker, Martin [38 ]
Ozkan, Hilal [24 ]
Sarafidis, Kosmas [55 ]
Hopper, Andrew O. [83 ]
Karen, Tanja [37 ]
Rzepecka-Weglarz, Beata [29 ]
Oguz, Serife S. [23 ]
Arruza, Luis [12 ]
Memisoglu, Asli C. [25 ]
del Rio Florentino, Ruth [14 ]
Baserga, Mariana [84 ]
Maton, Pierre [44 ]
Truttmann, Anita C. [39 ,40 ]
de las Cuevas, Isabel [15 ,16 ]
Agergaard, Peter [6 ]
Zafra, Pamela [17 ]
Bender, Lars [7 ]
Lauterbach, Ryszard [30 ]
Lecart, Chantal [45 ]
de Buyst, Julie
El-Khuffash, Afif [62 ]
Curley, Anna [63 ]
Vaccarello, Olalla O. [18 ]
Miletin, Jan [64 ,65 ,67 ]
Papathoma, Evangelia [56 ,57 ]
Vesoulis, Zachary [85 ]
Vento, Giovanni [51 ]
Cornette, Luc [47 ]
机构
[1] Copenhagen Univ Hosp, Rigshosp, Dept Neonatol, Copenhagen, Denmark
[2] Rigshosp, Copenhagen Univ Hosp, Dept Intens Care, Copenhagen, Denmark
[3] Rigshosp, Copenhagen Univ Hosp, Copenhagen Trial Unit, Ctr Clin Intervent Res,Capital Reg, Copenhagen, Denmark
[4] Rigshosp, Copenhagen Univ Hosp, Dept Neuroanesthesiol, Neurosci Ctr, Copenhagen, Denmark
[5] Univ Copenhagen, Sect Biostat, Dept Publ Hlth, Copenhagen, Denmark
[6] Aarhus Univ Hosp, Neonatal Intens Care Unit, Aarhus, Denmark
[7] Aalborg Univ Hosp, Dept Neonatol, Aalborg, Denmark
[8] Univ Southern Denmark, Dept Pediat, Odense Univ Hosp, Odense, Denmark
[9] Univ Southern Denmark, Dept Reg Hlth Res, Fac Hlth Sci, Odense, Denmark
[10] La Paz Univ Hosp, Dept Neonatol, Madrid, Spain
[11] 12 Octubre Univ Hosp, Neonatol Dept, Madrid, Spain
[12] Hosp Clin San Carlos, Inst Invest Sanitaria San Carlos, Dept Neonatol, Inst Nino Adolescente, Madrid, Spain
[13] Hosp Clin Barcelona, BCNatal Barcelona Ctr Maternal Fetal & Neonatal M, Dept Neonatol, Barcelona, Spain
[14] Hosp San Juan Dios, Dept Neonatol, Barcelona, Spain
[15] Cantabria Univ, Neonatal Unit, Marques Valdecilla Univ Hosp, Santander, Spain
[16] Cantabria Univ, Dept Med & Surg Sci, Santander, Spain
[17] Puerta Mar Univ Hosp, Neonatal Intens Care Unit, Cadiz, Spain
[18] Hosp Univ Tarragona Juan XXIII, Dept Neonatol, Tarragona, Spain
[19] Univ Hosp Virgen de las Nieves, Neonatal Unit, Granada, Spain
[20] Univ Hosp Cruces, Div Neonatol, Biocruces Hlth Res Inst, Baracaldo, Spain
[21] Miguel Servet Univ Hosp, Neonatol Div, Zaragoza, Spain
[22] Gazi Univ Hosp, Div Newborn Med, Ankara, Turkiye
[23] Univ Hlth Sci, Ankara City Hosp, Dept Neonatol, NICU, Ankara, Turkiye
[24] Bursa Uludag Univ, Fac Med, Dept Neonatol, Bursa, Turkiye
[25] Marmara Univ, Res & Educ Hosp, Sch Med, Div Neonatol,Dept Pediat, Istanbul, Turkiye
[26] Kanuni Sultan Suleyman Training & Res Hosp, Dept Neonatol, Istanbul, Turkiye
[27] Basaksehir Cam & Sakura City Hosp, Basaksehir, Turkiye
[28] Poznan Univ Med Sci, Dept Neonatol 2, Neonatal Biophys Monitoring & Cardiopulm Therapie, Poznan, Poland
[29] Centrum Med Ujastek, Dept Neonatol, Krakow, Poland
[30] Jagiellonian Univ Hosp, Dept Neonatol, Krakow, Poland
[31] Warsaw Univ Med Sci, Warsaw, Poland
[32] Ctr Postgrad Med Educ, Neonatol Dept, Warsaw, Poland
[33] Copernicus Univ Torun, Neonatal Unit, Bytom 2, Coll Medicum Bydgoszcz Nicolaus, Bydgoszcz, Poland
[34] Nicolaus Copernicus Univ Torun, Coll Medicum Bydgoszcz, Dept Neonatol, Bydgoszcz, Poland
[35] Wroclaw Med Univ, Dept Neonatol, Wroclaw, Poland
[36] Childrens Univ Hosp Zurich, Pediat Intens Care & Neonatol, Zurich, Switzerland
[37] Univ Hosp Zurich, Dept Neonatol, Zurich, Switzerland
[38] Childrens Hosp Lucerne, Intens Care Unit, Lausanne, Switzerland
[39] Univ Hosp Ctr, Dept Women Mother & Child, Clin Neonatol, Lausanne, Switzerland
[40] Univ Lausanne, Lausanne, Switzerland
[41] Childrens Univ Hosp Geneva, Div Neonatol & Pediat Intens Care, Geneva, Switzerland
[42] Univ Geneva, Geneva, Switzerland
[43] Katholieke Univ Leuven, Dept Dev & Regenerat, Leuven, Belgium
[44] Clin Ctr Hosp Chretien Montlegia Liege Belgium, Serv Neonatol, Liege, Belgium
[45] Grand Hop Charleroi, Dept Neonatol, Charleroi, Belgium
[46] NICU, Tivoli Hosp, La Louviere, Belgium
[47] Algemeen Ziekenhuis St Jan Bruges, Dept Neonatol, Brugge, Belgium
[48] Mountainside Med Ctr, Dept Pediat, Div Newborn Med, Montclair, NJ USA
[49] Univ Milan, Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy
[50] Univ Milan, Dept Clin Sci & Community Hlth, Milan, Italy
关键词
BLOOD-FLOW; TIME;
D O I
10.1056/NEJMoa2207554
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.) Cerebral Oximetry in Extremely Preterm Infants In extremely preterm infants, the use of cerebral oximetry monitoring to guide treatment for the first 72 hours after birth did not reduce the risk of death or severe brain injury at 36 weeks' postmenstrual age.
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收藏
页码:1501 / 1511
页数:11
相关论文
共 28 条
[1]   Neurodevelopmental Impairment Among Extremely Preterm Infants in the Neonatal Research Network [J].
Adams-Chapman, Ira ;
Heyne, Roy J. ;
DeMauro, Sara B. ;
Duncan, Andrea F. ;
Hintz, Susan R. ;
Pappas, Athina ;
Vohr, Betty R. ;
McDonald, Scott A. ;
Das, Abhik ;
Newman, Jamie E. ;
Higgins, Rosemary D. .
PEDIATRICS, 2018, 141 (05)
[2]   National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications [J].
Blencowe, Hannah ;
Cousens, Simon ;
Oestergaard, Mikkel Z. ;
Chou, Doris ;
Moller, Ann-Beth ;
Narwal, Rajesh ;
Adler, Alma ;
Garcia, Claudia Vera ;
Rohde, Sarah ;
Say, Lale ;
Lawn, Joy E. .
LANCET, 2012, 379 (9832) :2162-2172
[3]   Changes in hemodynamics, cerebral oxygenation and cerebrovascular reactivity during the early transitional circulation in preterm infants [J].
da Costa, Cristine Sortica ;
Cardim, Danilo ;
Molnar, Zoltan ;
Kelsall, Wilf ;
Ng, Isabel ;
Czosnyka, Marek ;
Smielewski, Peter ;
Austin, Topun .
PEDIATRIC RESEARCH, 2019, 86 (02) :247-253
[4]   Better Late Than Never? Deferred Consent for Minimal Risk Research in the ICU [J].
Duvall, Melody G. ;
Burns, Jeffrey P. .
CRITICAL CARE MEDICINE, 2017, 45 (09) :1571-1572
[5]  
European Medicines Agency, 2016, GUID GOOD CLIN PRACT
[6]   Research ethics committee decision-making in relation to an efficient neonatal trial [J].
Gale, C. ;
Hyde, M. J. ;
Modi, N. .
ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, 2017, 102 (04) :F291-F298
[7]   Hypoxia-ischemia is not an antecedent of most preterm brain damage: the illusion of validity [J].
Gilles, Floyd ;
Gressens, Pierre ;
Dammann, Olaf ;
Leviton, Alan .
DEVELOPMENTAL MEDICINE AND CHILD NEUROLOGY, 2018, 60 (02) :120-125
[8]   The international classification of retinopathy of prematurity revisited [J].
Gole, GA ;
Ells, AL ;
Katz, X ;
Holmstrom, G ;
Fielder, AR ;
Capone, A ;
Flynn, JT ;
Good, WG ;
Holmes, JM ;
McNamara, JA ;
Palmer, EA ;
Quinn, GE ;
Shapiro, MJ ;
Trese, MGJ ;
Wallace, DK .
ARCHIVES OF OPHTHALMOLOGY, 2005, 123 (07) :991-999
[9]   Autoregulation of cerebral blood flow in newborn babies [J].
Greisen, G .
EARLY HUMAN DEVELOPMENT, 2005, 81 (05) :423-428
[10]  
Greisen G, 2001, BIOL NEONATE, V79, P194