Evidence map›Paper›PMID 30894226›Full record

ArticleTrials2019

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.

Gerhard Pichler, Sigrid Baumgartner, Marlene Biermayr, Eugene Dempsey, Hans Fuchs, Tom G Goos, Gianluca Lista, Laila Lorenz, Lukasz Karpinski, Souvik Mitra and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03166722 (Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 2 pooled it
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03166722 nacompletednot on this map

Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth: An Investigator-initiated Randomised Multi-centre Multinational Clinical Trial

TypeinterventionalSponsorMedical University of GrazRan2017 to 2022Enrolled655ConditionsPreterm Infant, Brain Injuries, Birth HypoxiaArmsControl group, Study group
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
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  11. aEEG in the first 3 days after extremely preterm delivery relates to neurodevelopmental outcomes.Journal of perinatology : official journal of the California Perinatal Association · 2024
    Article
  12. Review
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  15. Article
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  18. Association of early cerebral oxygen saturation and brain injury in extremely preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2022
    Article
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 8 countries.

Gerhard PichlerResearch Unit for Neonatal Micro- and Macrocirculation, Division of Neonatology, Department of Paediatrics, Medical University of Graz, Auenbruggerplatz 30, 8036, Graz, Austria. gerhard.pichler@medunigraz.at.ORCID http://orcid.org/0000-0003-2405-7143
Sigrid BaumgartnerUniversitätsklinik für Kinder- und Jugendheilkunde Abteilung für Neonatologie, Pädiatrische Intensivmedizin und Neuropädiatrie, Medizinische Universität Wien, Währingergürtel 18-20, Wien, 1090, Austria.
Marlene BiermayrDepartment of Paediatrics II, Neonatology, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innsbruck, 6020, Austria.
Eugene DempseyInfant Centre, University College Cork, Cork University Maternity Hospital, Wilton, Cork, Ireland.
Hans FuchsCenter for Pediatrics, Department of Neonatology, Faculty of Medicine, Medical Center-University of Freiburg, Mathildenstrasse 1, Freiburg, 79106, Germany.
Tom G GoosDepartment of Pediatrics, Division of Neonatology, Erasmus MC-Sophia Children's Hospital, Wytemaweg 80, Rotterdam, 3015, the Netherlands.
Gianluca ListaNeonatologia e Terapia Intensiva Neonatale (TIN) Ospedale dei Bambini "V.Buzzi", Via Castelvetro 32, Milano, 20154, Italy.
Laila LorenzDepartment of Neonatology, University Children's Hospital of Tübingen, Calwerstrasse 7, Tübingen, 72076, Germany.
Lukasz KarpinskiPoznan University of Medical Sciences, Fredry 10, Poznan, 61-701, Poland.
Souvik MitraDivision of Neonatal-Perinatal Medicine, IWK Health Centre, University Avenue 5980, Halifax, B3K 6R8, Nova Scotia, Canada.
Lilijana Kornhauser-CerarNICU, Division for Perinatology, University Medical Centre Ljubljana, Zaloska cesta 7, Ljubljana, 1000, Slovenia.
Alexander AvianInstitute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Auenbruggerplatz 2, Graz, 8036, Austria.
Berndt UrlesbergerResearch Unit for Cerebral Development and Oximetry Research, Division of Neonatology, Department of Paediatrics, Medical University of Graz, Auenbruggerplatz 30, Graz, 8036, Austria.
Georg M SchmölzerCentre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Kingsway Avenue 10240, Edmonton, T5H 3V9, Alberta, Canada.
Medical University of Graz · ATErasmus MC - Sophia Children’s Hospital · NLInnsbruck Medical University · ATIzaak Walton Killam Health Centre · CALjubljana University Medical Centre · SIOspedale dei Bambini Vittore Buzzi · ITPoznan University of Medical Sciences · PLUniversitätsklinik für Kinder und Jugendpsychiatrie · ATUniversity Children's Hospital Tübingen · DEUniversity College Cork · IEUniversity of Alberta · CAUniversity of Freiburg · DE

Funding

Austrian Science Fund FWF KLI 615Fonds zur Förderung der wissenschaftlichen Forschung - FWF (AT) KlI 586-B31
6 · The paper itself

Abstract

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 than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO METHODS/

designCOSGOD 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 crSO DISCUSSION: crSO

trial registrationClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.

Indexed as

BrainOxygenCardiotocographyClinical Trials, Phase III as TopicHumansInfant, NewbornInfant, PrematureMulticenter Studies as TopicOutcome Assessment, Health CarePractice Guidelines as TopicRandomized Controlled Trials as TopicResearch DesignSpectroscopy, Near-InfraredOxygenCerebral injuryCerebral oxygenationImmediate transitionMortalityNeonate

Identifiers

PMID30894226
PMCPMC6427901
OpenAlexW2939506473

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.