Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth

Medical University of Graz192 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

192

Conditions

Neonatal Adaptation

Interventions

No InterventionOTHER

no intervention

Eligibility

Sex: ALLMin age: 0 MinutesMax age: 15 MinutesHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Division of Neonatology, Medical University of Graz

Graz, Austria

Outcomes

Primary Outcomes

Change of cerebral tissue oxygen saturation (crSO2) level

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.

Time frame: At each minute from minute 1 to minute 15 after birth

Data from ClinicalTrials.gov

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