Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial

被引：30

作者：

Pichler, Gerhard ^{[1
]}

Baumgartner, Sigrid ^{[2
]}

Biermayr, Marlene ^{[3
]}

Dempsey, Eugene ^{[4
]}

Fuchs, Hans ^{[5
]}

Goos, Tom G. ^{[6
,7
]}

Lista, Gianluca ^{[8
]}

Lorenz, Laila ^{[9
]}

Karpinski, Lukasz ^{[10
]}

Mitra, Souvik ^{[11
]}

Kornhauser-Cerar, Lilijana ^{[12
]}

Avian, Alexander ^{[13
]}

Urlesberger, Berndt ^{[14
]}

Schmoelzer, Georg M. ^{[15
,16
]}

机构：

[1] Med Univ Graz, Div Neonatol, Dept Paediat, Res Unit Neonatal Micro & Macrocirculat, Auenbruggerpl 30, A-8036 Graz, Austria

[2] Med Univ Wien, Univ Klin Kinder & Jugendheilkunde, Abt Neonatol Padiat Intens Med & Neuropadiatrie, Wahringergurtel 18-20, A-1090 Vienna, Austria

[3] Med Univ Innsbruck, Neonatol, Dept Paediat 2, Christoph Probst Pl 1, A-6020 Innsbruck, Austria

[4] Univ Coll Cork, Cork Univ Matern Hosp, Infant Ctr, Cork, Ireland

[5] Med Ctr Univ Freiburg, Dept Neonatol, Ctr Pediat, Fac Med, Mathildenstr 1, D-79106 Freiburg, Germany

[6] Erasmus MC Sophia Childrens Hosp, Div Neonatol, Dept Pediat, Wytemaweg 80, NL-3015 Rotterdam, Netherlands

[7] Delft Univ Technol, Dept Biomech Engn, Fac Mech Maritime & Mat Engn, Mekelweg 5, NL-2628 Delft, Netherlands

[8] Osped Bambini V Buzzi, Neonatol & Terapia Intens Neonatale TIN, Via Castelvetro 32, I-20154 Milan, Italy

[9] Univ Childrens Hosp Tubingen, Dept Neonatol, Calwerstr 7, D-72076 Tubingen, Germany

[10] Poznan Univ Med Sci, Fredry 10, PL-61701 Poznan, Poland

[11] IWK Hlth Ctr, Div Neonatal Perinatal Med, Univ Ave 5980, Halifax, NS B3K 6R8, Canada

[12] Univ Med Ctr Ljubljana, Div Perinatol, NICU, Zaloska Cesta 7, Ljubljana 1000, Slovenia

[13] Med Univ Graz, Inst Med Informat Stat & Documentat, Auenbruggerpl 2, A-8036 Graz, Austria

[14] Med Univ Graz, Div Neonatol, Dept Paediat, Res Unit Cerebral Dev & Oximetry Res, Auenbruggerpl 30, A-8036 Graz, Austria

[15] Royal Alexandra Hosp, Neonatal Res Unit, Ctr Studies Asphyxia & Resuscitat, Kingsway Ave 10240, Edmonton, AB T5H 3V9, Canada

[16] Univ Alberta, Dept Pediat, Kingsway Ave 10240, Edmonton, AB T5H 3V9, Canada

来源：

TRIALS | 2019年 / 20卷 / 1期

关键词：

Neonate; Cerebral oxygenation; Immediate transition; Cerebral injury; Mortality; RESUSCITATION; BRAIN; FETAL;

D O I：

10.1186/s13063-019-3258-y

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundTransition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury.The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than32weeks of gestation by targeting cerebral tissue oxygen saturation (crSO(2)) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15min) in addition to the routine monitoring of arterial oxygen saturation (SpO(2)) and heart rate (HR).Methods/DesignCOSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these.The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO(2), SpO(2), and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO(2) and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15min after birth during the immediate transition period and resuscitation. Thereafter, each neonate will be followed up for primary outcome to term date or discharge. The primary outcome is mortality or cerebral injury (or both) defined as any intra-ventricular bleeding or cystic periventricular leukomalacia (or both). Secondary outcomes are neonatal morbidities.DiscussioncrSO(2) monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO(2) with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury.Trial registrationClinicalTrials.gov Identifier: NCT03166722. Registered March 5, 2017.

引用

页数：10

共 32 条

[1] Cerebral Near-Infrared Spectroscopy during Transition of Healthy Term Newborns [J].