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

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dc.contributor.author Pichler, Gerhard
dc.contributor.author Baumgartner, Sigrid
dc.contributor.author Biermayr, Marlene
dc.contributor.author Dempsey, Eugene M.
dc.contributor.author Fuchs, Hans
dc.contributor.author Goos, Tom G.
dc.contributor.author Lista, Gianluca
dc.contributor.author Lorenz, Laila
dc.contributor.author Karpinski, Lukasz
dc.contributor.author Mitra, Souvik
dc.contributor.author Kornhauser-Cerar, Lilijana
dc.contributor.author Avian, Alexander
dc.contributor.author Urlesberger, Berndt
dc.contributor.author Schmölzer, Georg M.
dc.date.accessioned 2019-11-19T12:07:18Z
dc.date.available 2019-11-19T12:07:18Z
dc.date.issued 2019-03-20
dc.identifier.citation Pichler, G., Baumgartner, S., Biermayr, M., Dempsey, E., Fuchs, H., Goos, T.G., Lista, G., Lorenz, L., Karpinski, L., Mitra, S. and Kornhauser-Cerar, L., 2019. 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. Trials, 20(1), (178). DOI:10.1186/s13063-019-3258-y en
dc.identifier.volume 20 en
dc.identifier.issued 1 en
dc.identifier.startpage 1 en
dc.identifier.endpage 10 en
dc.identifier.uri http://hdl.handle.net/10468/9082
dc.identifier.doi 10.1186/s13063-019-3258-y en
dc.description.abstract Transition 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 than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO2) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15 min) in addition to the routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR). Methods/Design: COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks 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 crSO2, SpO2, and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO2 and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15 min 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. Discussion: crSO2 monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO2 with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury. Trial registration ClinicalTrials.gov Identifier: NCT03166722 en
dc.description.sponsorship KLI 586-B31 en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BioMed Central Ltd. en
dc.relation.uri https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3258-y
dc.rights © The Author(s) 2019 en
dc.rights.uri https://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated en
dc.subject Neonate en
dc.subject Cerebral oxygenation en
dc.subject Immediate transition en
dc.subject Cerebral injury en
dc.subject Mortality en
dc.title 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 en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Eugene Dempsey, Department of Paediatrics and Child Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: g.dempsey@ucc.ie en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder Austrian Science Fund en
dc.contributor.funder University of Alberta en
dc.contributor.funder Heart and Stroke Foundation Canada en
dc.contributor.funder Heart and Stroke Foundation Alberta en
dc.contributor.funder Stollery Children's Hospital Foundation en
dc.description.status Peer reviewed en
dc.identifier.journaltitle Trials en
dc.internal.IRISemailaddress g.dempsey@ucc.ie en
dc.identifier.articleid 178 en
dc.identifier.eissn 1745-6215


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