Preterm InfantCOSGODNCT03166722
Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition
A study testing Study group in people with Preterm Infant and Brain Injuries, run by Medical University of Graz at 12 sites in 7 countries.
Trial summary
The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and heart rate and specified clinical… Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutes
- Conditions the study is for
- Preterm Infant, Brain Injuries, Birth Hypoxia
- What is being tested?
- Study group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 20 Sep 2017to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 15 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates less than completed 32 weeks,
- Decision to conduct full life support,
- Written informed consent.
Who cannot join
- No decision to conduct full life support,
- No written informed consent,
- Congenital malformation.
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Austria3 sites
Department of Pediatrics, Medical University of Graz
Graz, Styria, 8036
Medical University Innsbruck
Innsbruck
Medical University Vienna
Vienna
Germany2 sites
Universitätsklinikum Freiburg
Freiburg im Breisgau
Centre for Pediatric Clinical Studies
Tübingen
Italy2 sites
Ospedale dei Bambini "V.Buzzi" Milano
Milan
Institute for Maternal and Child Health, IRCCS Burlo Garofolo
Trieste
Poland2 sites
Poznan University of Medical Sciences
Poznan
Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan
About this study
Official title: 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
The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and heart rate and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
Read the detailed description
Background
The transition to life after birth is a complex physiological process where the neonate has to establish sufficient ventilation and changes from intra-uterine circulation to extra-uterine circulation take place. During these processes the neonate has to provide the brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue oxygenation and activity. If hypoxia and bradycardia both common events during immediate transition in preterm neonates occur, cerebral hypoxia-ischaemia may cause perinatal brain injury that is the major causes of mortality and long term neurodevelopmental impairment.
Objectives
The primary objective of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR) and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
Hypothesis
The investigators hypothesise that using cerebral tissue oxygen saturation in addition to SpO2 and HR monitoring and specified treatment guidelines during immediate transition and resuscitation would increase survival without cerebral injury in preterm neonates.
Trial design
An investigator-initiated randomised, multi-centre, multinational, phase III clinical trial involving preterm infants from European countries and North America.
Inclusion and exclusion criteria
The inclusion criteria are: neonates born more than 8 weeks preterm (gestational age up to 31 weeks and 6 days); decision to conduct full life support; parental informed consent; and cerebral NIRS oximeter placed within three minutes after birth.
Sample size
According to actual data of two European centres (Graz and Rotterdam) and one Canadian centre (Edmonton) the percentage of neonates not affected by mortality and cerebral injury is 65%. Assuming an increase of not affected neonates from 65% to 75% and a dropout rate of 10% a total of 724 neonates are required to detect this difference with a two group χ² test (alpha: 0.05, power: 80%).
Intervention
The premature infants will be randomised into experimental or control group. Both groups will have a near infrared spectroscopy (NIRS) device (left frontal), pulse-oximeter (right wrist) and electrocardiogram placed within three minutes after birth. In the study group, the cerebral tissue saturation, SpO2 and HR readings are visible, and the infant will be treated accordingly using a defined treatment guideline. In the control group, only SpO2 and HR will be visible, and the infant will be treated according routine treatment.
Duration of intervention Monitoring will be started within 3 minutes after birth and the intervention will last during immediate transition period and resuscitation up to 15 minutes after birth.
Follow up
Thereafter, each neonate will be followed up for primary outcome to term date or discharge.
Outcome measures
The primary outcome is mortality and/or cerebral injury defined as any intraventricular bleeding and/or cystic periventricular leucomalacia.
The secondary outcomes are neonatal morbidities.
- Conditions
- Preterm Infant, Brain Injuries, Birth Hypoxia
- Being tested
- Control group, Study group
- Medical subject headings
- Premature Birth, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
SpO2 and HR monitoring and routine treatment during immediate transition
Study groupDevice
Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring
| Study group | Role | What they receive |
|---|---|---|
| Study group: Invos 5100 | Experimental | Supplemental oxygen support and respiratory/circulatory support is guided by cerebral regional tissue oxygenation (crSO2) measured with near-infrared spectroscopy ("INVOS 5100" ), in addition to the SpO2/HR (oxygen saturation/heart rate) monitoring according to routine. Receives: Device: Study group |
| Control group: Routine care | Active comparator | Supplemental oxygen support and respiratory/circulatory support is guided by SpO2/HR monitoring according to routine - The resuscitation team is blinded to the crSO2 monitoring. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and/or occurrence of cerebral injury
Number of patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
Measured: up to 19 weeks after birth
Secondary outcomes (3)
Frequency of neonatal morbidities
Number of patients, who have infection and/or sepsis and/or necrotizing enterocolitis bronchoplumonary dysplasia, retinopathia prematurorumand/or bronchoplumonary dysplasia and /or retinopathia prematurorum
Measured: up to 19 weeks after birth
Sex
Number of male and female patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
Measured: up to 19 weeks after birth
Gestational age
Number of patients with less than 28 weeks of gestation and more than or equal 28 weeks of gestation, who die or have intraventricular hemorrhage or have periventricular leucomalacia
Measured: up to 19 weeks after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start20 Sep 2017
- Primary completion31 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- investigator-initiated randomised multi-centre multinational clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Gerhard Pichler, MD, Principal investigator, Medical University of GrazGeorg M Schmölzer, MD, PhD, Principal investigator, Royal Alexandra Hospital, Edmonton, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166722
- Sponsor's protocol ID
- COSGOD Phase III
- Acronym
- COSGOD
- Status last verified
- Feb 2022
- First submitted
- 3 May 2017
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The demographic data and data of primary and secondary outcome will be stored at and available form the Institut for Medical Informatics, Statistics und Documentation, Medical University of Graz, Austria
Publications
Perme T, Kornhauser Cerar L, Schwaberger B, Urlesberger B, Wolfsberger CH, Baik N, Goeral K, Hammerl M, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law BHY, Buchmayer J, Kiechl-Kohlendorfer U, Schwarz CE, Gruendler K, Stucchi I, Klebermass-Schrehof K, Schmolzer GM, Pichler G; COSGOD III study group. Effect of timing of umbilical cord clamping on cerebral regional tissue oxygenation: a secondary analysis of the COSGOD III trial. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):610-615. doi: 10.1136/archdischild-2024-327946.
PubMed 40306760Wolfsberger CH, Schwaberger B, Urlesberger B, Avian A, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Law B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Klebermass-Schrehof K, Schmolzer GM, Pichler G; COSGOD III study group. Reference Ranges for Arterial Oxygen Saturation, Heart Rate, and Cerebral Oxygen Saturation during Immediate Postnatal Transition in Neonates Born Extremely or Very Preterm. J Pediatr. 2024 Oct;273:114132. doi: 10.1016/j.jpeds.2024.114132. Epub 2024 May 31.
PubMed 38823628Pichler G, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law B, Urlesberger B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Schwaberger B, Klebermass-Schrehof K, Schmolzer GM; COSGOD III study group. 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. BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.
PubMed 36693654Pichler G, Baumgartner S, Biermayr M, Dempsey E, Fuchs H, Goos TG, Lista G, Lorenz L, Karpinski L, Mitra S, Kornhauser-Cerar L, Avian A, Urlesberger B, Schmolzer GM. 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. 2019 Mar 20;20(1):178. doi: 10.1186/s13063-019-3258-y.
PubMed 30894226
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03166722
- Acronym / sponsor ID
- COSGOD / COSGOD Phase III
- Conditions
- Preterm Infant, Brain Injuries, Birth Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation and heart rate and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
Detailed description
Background
The transition to life after birth is a complex physiological process where the neonate has to establish sufficient ventilation and changes from intra-uterine circulation to extra-uterine circulation take place. During these processes the neonate has to provide the brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue oxygenation and activity. If hypoxia and bradycardia both common events during immediate transition in preterm neonates occur, cerebral hypoxia-ischaemia may cause perinatal brain injury that is the major causes of mortality and long term neurodevelopmental impairment.
Objectives
The primary objective of the COSGOD Phase III trial is to examine, if it is possible to increase survival without cerebral injury in preterm neonates <32 weeks of gestation by monitoring the cerebral tissue oxygen saturation in addition to routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR) and specified clinical treatment guidelines during immediate transition period after birth (the first 15 minutes).
Hypothesis
The investigators hypothesise that using cerebral tissue oxygen saturation in addition to SpO2 and HR monitoring and specified treatment guidelines during immediate transition and resuscitation would increase survival without cerebral injury in preterm neonates.
Trial design
An investigator-initiated randomised, multi-centre, multinational, phase III clinical trial involving preterm infants from European countries and North America.
Inclusion and exclusion criteria
The inclusion criteria are: neonates born more than 8 weeks preterm (gestational age up to 31 weeks and 6 days); decision to conduct full life support; parental informed consent; and cerebral NIRS oximeter placed within three minutes after birth.
Sample size
According to actual data of two European centres (Graz and Rotterdam) and one Canadian centre (Edmonton) the percentage of neonates not affected by mortality and cerebral injury is 65%. Assuming an increase of not affected neonates from 65% to 75% and a dropout rate of 10% a total of 724 neonates are required to detect this difference with a two group χ² test (alpha: 0.05, power: 80%).
Intervention
The premature infants will be randomised into experimental or control group. Both groups will have a near infrared spectroscopy (NIRS) device (left frontal), pulse-oximeter (right wrist) and electrocardiogram placed within three minutes after birth. In the study group, the cerebral tissue saturation, SpO2 and HR readings are visible, and the infant will be treated accordingly using a defined treatment guideline. In the control group, only SpO2 and HR will be visible, and the infant will be treated according routine treatment.
Duration of intervention Monitoring will be started within 3 minutes after birth and the intervention will last during immediate transition period and resuscitation up to 15 minutes after birth.
Follow up
Thereafter, each neonate will be followed up for primary outcome to term date or discharge.
Outcome measures
The primary outcome is mortality and/or cerebral injury defined as any intraventricular bleeding and/or cystic periventricular leucomalacia.
The secondary outcomes are neonatal morbidities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- investigator-initiated randomised multi-centre multinational clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study group: Invos 5100 | Experimental | Device: Study groupSupplemental oxygen support and respiratory/circulatory support is guided by cerebral regional tissue oxygenation (crSO2) measured with near-infrared spectroscopy ("INVOS 5100" ), in addition to the SpO2/HR (oxygen saturation/heart rate) monitoring according to routine. |
| Control group: Routine care | Active comparator | Other: Control groupSupplemental oxygen support and respiratory/circulatory support is guided by SpO2/HR monitoring according to routine - The resuscitation team is blinded to the crSO2 monitoring. |
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm neonates less than completed 32 weeks,
- Decision to conduct full life support,
- Written informed consent.
Key exclusion criteria (3 listed)
- No decision to conduct full life support,
- No written informed consent,
- Congenital malformation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupSpO2 and HR monitoring and routine treatment during immediate transition | Other | Control group: Routine care |
| Study groupCerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring | Device | Study group: Invos 5100 |
Primary outcome
Mortality and/or occurrence of cerebral injury
Time frame: up to 19 weeks after birth
Number of patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
3 secondary outcomes
Frequency of neonatal morbidities
Time frame: up to 19 weeks after birth
Sex
Time frame: up to 19 weeks after birth
Gestational age
Time frame: up to 19 weeks after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 40306760Perme T, Kornhauser Cerar L, Schwaberger B, Urlesberger B, Wolfsberger CH, Baik N, Goeral K, Hammerl M, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law BHY, Buchmayer J, Kiechl-Kohlendorfer U, Schwarz CE, Gruendler K, Stucchi I, Klebermass-Schrehof K, Schmolzer GM, Pichler G; COSGOD III study group. Effect of timing of umbilical cord clamping on cerebral regional tissue oxygenation: a secondary analysis of the COSGOD III trial. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):610-615. doi: 10.1136/archdischild-2024-327946.
- Derived from this study: PubMed 38823628Wolfsberger CH, Schwaberger B, Urlesberger B, Avian A, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Law B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Klebermass-Schrehof K, Schmolzer GM, Pichler G; COSGOD III study group. Reference Ranges for Arterial Oxygen Saturation, Heart Rate, and Cerebral Oxygen Saturation during Immediate Postnatal Transition in Neonates Born Extremely or Very Preterm. J Pediatr. 2024 Oct;273:114132. doi: 10.1016/j.jpeds.2024.114132. Epub 2024 May 31.
- Derived from this study: PubMed 36693654Pichler G, Goeral K, Hammerl M, Perme T, Dempsey EM, Springer L, Lista G, Szczapa T, Fuchs H, Karpinski L, Bua J, Avian A, Law B, Urlesberger B, Buchmayer J, Kiechl-Kohlendorfer U, Kornhauser-Cerar L, Schwarz CE, Grundler K, Stucchi I, Schwaberger B, Klebermass-Schrehof K, Schmolzer GM; COSGOD III study group. 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. BMJ. 2023 Jan 24;380:e072313. doi: 10.1136/bmj-2022-072313.
- Derived from this study: PubMed 30894226Pichler G, Baumgartner S, Biermayr M, Dempsey E, Fuchs H, Goos TG, Lista G, Lorenz L, Karpinski L, Mitra S, Kornhauser-Cerar L, Avian A, Urlesberger B, Schmolzer GM. 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. 2019 Mar 20;20(1):178. doi: 10.1186/s13063-019-3258-y.
- Individual participant dataSharing planned: Yes. The demographic data and data of primary and secondary outcome will be stored at and available form the Institut for Medical Informatics, Statistics und Documentation, Medical University of Graz, Austria
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Pichler, MD principal investigator
Medical University of Graz
Georg M Schmölzer, MD, PhD principal investigator
Royal Alexandra Hospital, Edmonton, Canada
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study group in people with Preterm Infant and Brain Injuries, run by Medical University of Graz at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria, Germany, Italy, Poland, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and/or occurrence of cerebral injury (time frame: up to 19 weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166722, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.