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 :
Recruiting
First Posted : May 25, 2017
Last Update Posted : July 1, 2020
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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) |
Estimated Enrollment : | 726 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 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | September 30, 2021 |

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 ]Number of patients, who die or have intraventricular hemorrhage or have periventricular leucomalacia
- Frequency of neonatal morbidities [ Time Frame: up to 19 weeks ]Number of patients, who have infection and/or sepsis and/or necrotizing enterocolitis and/or bronchoplumonary dysplasia and /or retinopathia prematurorum

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Ages Eligible for Study: | up 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
Contact: Gerhard Pichler, MD | +43 316 385 80520 | gerhard.pichler@medunigraz.at |
Austria | |
Department of Pediatrics, Medical University of Graz | Recruiting |
Graz, Styria, Austria, 8036 | |
Contact: Gerhard Pichler, MD 0043 316 385 80520 gerhard.pichler@medunigraz.at | |
Principal Investigator: Gerhard Pichler, MD | |
Canada, Alberta | |
Royal Alexandra Hospital | Recruiting |
Edmonton, Alberta, Canada, T5H 3V9 | |
Contact: Georg M Schmölzer, MD, PhD georg.schmoelzer@me.com |
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: | July 1, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |