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

Neonatal Adaptation Clinical Trial

— COIN  

Official title:

Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth - a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594824
• Other study ID #: 32-320 ex 19/2
• Status: Completed
• Start date: November 13, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: May 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Minutes to 15 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Adaptation

Intervention

Other:
• No Intervention
no intervention

Locations

Country	Name	City	State
Austria	Division of Neonatology, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At each minute from minute 1 to minute 15 after birth