Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Adaptation
- Sponsor
- Medical University of Graz
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Change of cerebral tissue oxygen saturation (crSO2) level
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Term and preterm neonates observed routinely at the resuscitation desk
- •Decision to conduct full life support
- •Written informed consent
- •Neonates who require no respiratory or medical support
Exclusion Criteria
- •No decision to conduct full life Support
- •No written informed consent
- •Congenital malformation
- •Neonates who require respiratory and/ or medical support
Outcomes
Primary Outcomes
Change of cerebral tissue oxygen saturation (crSO2) level
Time Frame: At each minute from minute 1 to minute 15 after birth
To measure cerebral oxygenation with Root (O3 regional oxymetry, Masimo, USA) non-invasively and continuously during the first 15 minutes after birth and establish the reference ranges in term and preterm neonates.