Evidence map›Paper›PMID 36693654›Full record

Trial reportBMJ (Clinical research ed.)2023

Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial.

Gerhard Pichler, Katharina Goeral, Marlene Hammerl, Tina Perme, Eugene M Dempsey, Laila Springer, Gianluca Lista, Tomasz Szczapa, Hans Fuchs, Lukasz Karpinski and 14 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ (Clinical research ed.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
12.4field-weighted citation impact, top 1% 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
NCT06141733 completednot on this mapstarted 2024, after this paper: background citation

2 Year Follow up of COSGOD III (COSGOD III-FU)- Ancillary Retrospective Observational Study to COSGOD III Trial

TypeobservationalSponsorMedical University of GrazRan2024 to 2024Enrolled417ConditionsNeurodevelopmental Disability, DeathArmsNIRS group
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 11 institutions in 7 countries.

Gerhard PichlerResearch Unit for Microcirculation and Macrocirculation of the Newborn, Medical University of Graz, Graz, Austria gerhard.pichler@medunigraz.at.ORCID 0000-0003-2405-7143
Katharina GoeralComprehensive Center for Pediatrics, Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Intensive Care and Neuropediatrics, Medical University of Vienna, Vienna, Austria.
Marlene HammerlDepartment of Pediatrics II, Neonatology, Medical University of Innsbruck, Innsbruck, Austria.
Tina PermeNICU, Department for Perinatology, Division of Gynaecology and Obstetrics, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Eugene M DempseyINFANT Research Centre, University College Cork, Cork University Maternity Hospital, Cork, Ireland.
Laila SpringerDepartment of Neonatology, University Children's Hospital of Tübingen, Tübingen, Germany.
Gianluca ListaNeonatologia e Terapia Intensiva Neonatale (TIN) Ospedale dei Bambini "V Buzzi," Milano, Italia.
Tomasz SzczapaII Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Chair of Neonatology, Poznan University of Medical Sciences, Poznan, Poland.
Hans FuchsDivision of Neonatology and Pediatric Intensive Care Medicine, Center for Pediatrics and Adolescent Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Lukasz KarpinskiII Department of Neonatology, Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Chair of Neonatology, Poznan University of Medical Sciences, Poznan, Poland.
Jenny BuaNeonatal Intensive Care Unit, Institute for Maternal and Child Health, "IRCCS Burlo Garofolo," Trieste, Italy.
Alexander AvianInstitute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria.
Brenda LawCentre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Edmonton, AB, Canada.
Berndt UrlesbergerResearch Unit for Microcirculation and Macrocirculation of the Newborn, Medical University of Graz, Graz, Austria.
Julia BuchmayerComprehensive Center for Pediatrics, Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Intensive Care and Neuropediatrics, Medical University of Vienna, Vienna, Austria.
Ursula Kiechl-KohlendorferDepartment of Pediatrics II, Neonatology, Medical University of Innsbruck, Innsbruck, Austria.
Lilijana Kornhauser-CerarNICU, Department for Perinatology, Division of Gynaecology and Obstetrics, University Medical Centre Ljubljana, Ljubljana, Slovenia.
Christoph E SchwarzINFANT Research Centre, University College Cork, Cork University Maternity Hospital, Cork, Ireland.
Kerstin GründlerDepartment of Neonatology, University Children's Hospital of Tübingen, Tübingen, Germany.
Ilaria StucchiNeonatologia e Terapia Intensiva Neonatale (TIN) Ospedale dei Bambini "V Buzzi," Milano, Italia.
Bernhard SchwabergerResearch Unit for Microcirculation and Macrocirculation of the Newborn, Medical University of Graz, Graz, Austria.
Katrin Klebermass-SchrehofComprehensive Center for Pediatrics, Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Intensive Care and Neuropediatrics, Medical University of Vienna, Vienna, Austria.
Georg M SchmölzerCentre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Edmonton, AB, Canada.
COSGOD III study group
Medical University of Graz · ATMedical University of Vienna · ATInnsbruck Medical University · ATLjubljana University Medical Centre · SIOspedale dei Bambini Vittore Buzzi · ITPoznan University of Medical Sciences · PLUniversity Children's Hospital Tübingen · DEUniversity College Cork · IEUniversity of Alberta · CAIRCCS Materno Infantile Burlo Garofolo · ITUniversity of Freiburg · DE

Funding

Austrian Science Fund FWF KLI 615
6 · The paper itself

Abstract

objectiveTo investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone.

designMulticentre, multinational, randomised controlled phase 3 trial.

setting11 tertiary neonatal intensive care units in six countries in Europe and in Canada.

participants1121 pregnant women (<32 weeks' gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group.

interventionPreterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation.

main outcome measureThe primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge.

resultsCerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%)

conclusionMonitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks' gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant.

trial registrationClinicalTrials.gov NCT03166722.

Indexed as

Brain InjuriesOxygenBrainFemaleGestational AgeHumansInfantInfant, NewbornInfant, PrematureOxygen SaturationPregnancyOxygen

Identifiers

PMID36693654
PMCPMC9871806
OpenAlexW4317903192

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.