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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 : September 24, 2019
Sponsor:
Collaborator:
Royal Alexandra Hospital
Information provided by (Responsible Party):
Medical University of Graz

Brief 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 treatment guidelines during immediate transition period after birth (the first 15 minutes).

Condition or disease Intervention/treatment Phase
Preterm Infant Brain Injuries Birth Hypoxia Other: Control group Device: Study group Not Applicable

  Show Detailed Description

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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 : December 31, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.
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.
Other: Control group
SpO2 and HR monitoring and routine treatment during immediate transition




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Gerhard Pichler, MD +43 316 385 80520 gerhard.pichler@medunigraz.at

Locations
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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   
Sponsors and Collaborators
Medical University of Graz
Royal Alexandra Hospital
Investigators
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Principal Investigator: Gerhard Pichler, MD Medical University of Graz, Austria
Principal Investigator: Georg M Schmölzer, MD, PhD Royal Alexandra Hospital, Edmonton, Canada

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03166722     History of Changes
Other Study ID Numbers: COSGOD Phase III
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Signs and Symptoms