Cerebral Oxygenation to Guide Supplemental Oxygen (COSGOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Pichler Gerhard, MD., Medical University of Graz
ClinicalTrials.gov Identifier:
NCT02017691
First received: November 28, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth.

Patients: Preterm neonates <34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study.

Design: A prospective two-centre randomized controlled pilot feasibility study

Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth.

Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 <10th or >90th centile in preterm neonates during the first 15 minutes after birth

Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 <10th or >90th centile.


Condition Intervention Phase
Oxygen Saturation
Device: Near Infrared Spectroscopy
Device: Pulse-oximetry
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cerebral Regional Tissue Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates During Immediate Transition After Birth (COSGOD) - a Prospective Two-centre Randomized Controlled Pilot Feasibility Study

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Cerebral tissue oxygen saturation (crSO2) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Duration in % minute of crSO2 <10th or >90th centile


Secondary Outcome Measures:
  • Mortality [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Rate of mortality

  • Cerebral injury [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Cerebral injury assessed by sonography

  • Neurodevelopmental outcome [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    General movements


Other Outcome Measures:
  • Morbidity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

    Severe morbidities, Rate of intubation during resuscitation, Need of mechanical ventilation on the first day of life,

    Monitoring parameters during the first 15minutes after birth:

    Mean (SD) HR, Mean (SD) BP, Mean (SD) SpO2, NIRS parameters



Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Near Infrared Spectroscopy
crSO2 measurements in addition SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth
Device: Near Infrared Spectroscopy
If crSO2 is <10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable >10th centile, or if crSO2 is > 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate.
Pulse-oximetry
Only SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth
Device: Pulse-oximetry
If SpO2 remains <10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is >90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate.

  Eligibility

Ages Eligible for Study:   up to 15 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm neonate <34+0 weeks after caesarean section
  • Decision to conduct full life support
  • Written informed consent

Exclusion Criteria:

  • No decision to conduct full life support
  • No written informed consent
  • Congenital malformation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017691

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

Locations
Austria
Department of Pediatrics, Medical University of Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Gerhard Pichler, MD    0043 316 385 80520    pichler.gerhard@klinikum-graz.at   
Principal Investigator: Gerhard Pichler, MD         
Canada, Alberta
Department of Pediatrics, Royal Alexandra Hospital Not yet recruiting
Edmonton, Alberta, Canada
Contact: Georg M Schmölzer, MD, PhD       georg.schmoelzer@me.com   
Principal Investigator: Georg M Schmölzer, MD, PhD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Gerhard Pichler, MD Dep. of Pediatrics, Medical University of Graz
  More Information

No publications provided

Responsible Party: Pichler Gerhard, MD., Assoc. Prof., Medical University of Graz
ClinicalTrials.gov Identifier: NCT02017691     History of Changes
Other Study ID Numbers: 25-295
Study First Received: November 28, 2013
Last Updated: May 8, 2014
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on August 21, 2014