Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition (COSGOD)
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ClinicalTrials.gov Identifier: NCT03166722 |
Recruitment Status :
Completed
First Posted : May 25, 2017
Last Update Posted : February 11, 2022
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Condition or disease | Intervention/treatment | Phase |
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Preterm Infant Brain Injuries Birth Hypoxia | Other: Control group Device: Study group | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 655 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | investigator-initiated randomised multi-centre multinational clinical trial |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Start Date : | September 20, 2017 |
Actual Primary Completion Date : | January 31, 2022 |
Actual Study Completion Date : | February 10, 2022 |

Arm | Intervention/treatment |
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Experimental: Study group: Invos 5100
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.
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Device: Study group
Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring |
Active Comparator: Control group: Routine care
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.
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Other: Control group
SpO2 and HR monitoring and routine treatment during immediate transition |
- 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
- Frequency of neonatal morbidities [ Time Frame: up to 19 weeks after birth ]Number of patients, who have infection and/or sepsis and/or necrotizing enterocolitis bronchoplumonary dysplasia, retinopathia prematurorumand/or bronchoplumonary dysplasia and /or retinopathia prematurorum
- Sex [ Time Frame: up to 19 weeks after birth ]Number of male and female patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
- Gestational age [ Time Frame: up to 19 weeks after birth ]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

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Ages Eligible for Study: | 1 Minute to 15 Minutes (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Preterm neonates less than completed 32 weeks,
- Decision to conduct full life support,
- Written informed consent.
Exclusion Criteria:
- No decision to conduct full life support,
- No written informed consent,
- Congenital malformation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166722
Austria | |
Department of Pediatrics, Medical University of Graz | |
Graz, Styria, Austria, 8036 | |
Medical University Innsbruck | |
Innsbruck, Austria | |
Medical University Vienna | |
Vienna, Austria | |
Canada, Alberta | |
Royal Alexandra Hospital | |
Edmonton, Alberta, Canada, T5H 3V9 | |
Germany | |
Universitätsklinikum Freiburg | |
Freiburg, Germany | |
Centre for Pediatric Clinical Studies | |
Tübingen, Germany | |
Ireland | |
University College Cork | |
Cork, Ireland | |
Italy | |
Ospedale dei Bambini "V.Buzzi" Milano | |
Milano, Italy | |
Institute for Maternal and Child Health, IRCCS Burlo Garofolo | |
Trieste, Italy | |
Poland | |
Poznan University of Medical Sciences | |
Poznań, Poland | |
Uniwersytetu Medycznego im. Karola Marcinkowskiego | |
Poznań, Poland | |
Slovenia | |
University Medical Centre Ljubljana | |
Ljubljana, Slovenia |
Principal Investigator: | Gerhard Pichler, MD | Medical University of Graz, Austria | |
Principal Investigator: | Georg M Schmölzer, MD, PhD | Royal Alexandra Hospital, Edmonton, Canada |
Responsible Party: | Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT03166722 |
Other Study ID Numbers: |
COSGOD Phase III |
First Posted: | May 25, 2017 Key Record Dates |
Last Update Posted: | February 11, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | After publication of primary and secondary outcome |
Access Criteria: | On demand |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Brain Injuries Premature Birth Hypoxia Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Signs and Symptoms, Respiratory |