Cerebral Oxygenation to Guide Supplemental Oxygen
COSGOD
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
1 other identifier
interventional
60
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 17, 2015
April 1, 2015
1.2 years
November 28, 2013
April 16, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral tissue oxygen saturation (crSO2)
Duration in % minute of crSO2 \<10th or \>90th centile
15 minutes
Secondary Outcomes (3)
Mortality
16 weeks
Cerebral injury
16 weeks
Neurodevelopmental outcome
16 weeks
Other Outcomes (1)
Morbidity
16 weeks
Study Arms (2)
Near Infrared Spectroscopy
EXPERIMENTALcrSO2 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
Pulse-oximetry
OTHEROnly 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
Interventions
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.
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 Criteria
You may qualify if:
- Preterm neonate \<34+0 weeks after caesarean section
- Decision to conduct full life support
- Written informed consent
You may not qualify if:
- No decision to conduct full life support
- No written informed consent
- Congenital malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Pediatrics, Medical University of Graz
Graz, Styria, 8036, Austria
Department of Pediatrics, Royal Alexandra Hospital
Edmonton, Alberta, Canada
Related Publications (1)
Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A, Pansy J, Cheung PY, Schmolzer GM. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr. 2016 Mar;170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30.
PMID: 26743498DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Pichler, MD
Dep. of Pediatrics, Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
November 28, 2013
First Posted
December 23, 2013
Study Start
December 1, 2013
Primary Completion
February 1, 2015
Study Completion
April 1, 2015
Last Updated
April 17, 2015
Record last verified: 2015-04