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

Completed

• Conditions: Neonatal Adaptation
• Interventions: Other: No Intervention

• Registration Number: NCT04594824
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-20
• Study Start: 2020-11-13
• Primary Completion: 2022-04-04
• Study Completion: 2022-04-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term neonates	No Intervention	-
Preterm neonates	No Intervention	-

Primary Outcome Measures

Name	Time	Method
Change of cerebral tissue oxygen saturation (crSO2) level	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.

Trial Locations

Locations (1)

Division of Neonatology, Medical University of Graz; 🇦🇹 Graz, Austria