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.authorPichler, Gerhard
dc.contributor.authorBaumgartner, Sigrid
dc.contributor.authorBiermayr, Marlene
dc.contributor.authorDempsey, Eugene M.
dc.contributor.authorFuchs, Hans
dc.contributor.authorGoos, Tom G.
dc.contributor.authorLista, Gianluca
dc.contributor.authorLorenz, Laila
dc.contributor.authorKarpinski, Lukasz
dc.contributor.authorMitra, Souvik
dc.contributor.authorKornhauser-Cerar, Lilijana
dc.contributor.authorAvian, Alexander
dc.contributor.authorUrlesberger, Berndt
dc.contributor.authorSchmölzer, Georg M.
dc.contributor.funderAustrian Science Funden
dc.contributor.funderUniversity of Albertaen
dc.contributor.funderHeart and Stroke Foundation Canadaen
dc.contributor.funderHeart and Stroke Foundation Albertaen
dc.contributor.funderStollery Children's Hospital Foundationen
dc.date.accessioned2019-11-19T12:07:18Z
dc.date.available2019-11-19T12:07:18Z
dc.date.issued2019-03-20
dc.description.abstractTransition 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: NCT03166722en
dc.description.sponsorshipKLI 586-B31en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid178en
dc.identifier.citationPichler, 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-yen
dc.identifier.doi10.1186/s13063-019-3258-yen
dc.identifier.eissn1745-6215
dc.identifier.endpage10en
dc.identifier.issued1en
dc.identifier.journaltitleTrialsen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/9082
dc.identifier.volume20en
dc.language.isoenen
dc.publisherBioMed Central Ltd.en
dc.relation.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3258-y
dc.rights© The Author(s) 2019en
dc.rights.urihttps://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 stateden
dc.subjectNeonateen
dc.subjectCerebral oxygenationen
dc.subjectImmediate transitionen
dc.subjectCerebral injuryen
dc.subjectMortalityen
dc.titleCerebral 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 trialen
dc.typeArticle (peer-reviewed)en
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