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Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition

NCT03166722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2022-02-11

No results posted yet for this study

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).

Conditions

  • Preterm Infant
  • Brain Injuries
  • Birth Hypoxia

Interventions

OTHER

Control group

SpO2 and HR monitoring and routine treatment during immediate transition

DEVICE

Study group

Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring

Sponsors & Collaborators

  • Royal Alexandra Hospital

    collaborator OTHER

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Gerhard Pichler, MD · Medical University of Graz, Austria

  • Georg M Schmölzer, MD, PhD · Royal Alexandra Hospital, Edmonton, Canada

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
15 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2022-01-31
Completion
2022-02-10

Countries

  • Austria
  • Canada
  • Germany
  • Ireland
  • Italy
  • Poland
  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166722 on ClinicalTrials.gov