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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Oxygen Saturation
- Sponsor
- Medical University of Graz
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Cerebral tissue oxygen saturation (crSO2)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Pichler Gerhard, MD.
Assoc. Prof.
Medical University of Graz
Eligibility 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
Outcomes
Primary Outcomes
Cerebral tissue oxygen saturation (crSO2)
Time Frame: 15 minutes
Duration in % minute of crSO2 \<10th or \>90th centile
Secondary Outcomes
- Cerebral injury(16 weeks)
- Mortality(16 weeks)
- Neurodevelopmental outcome(16 weeks)