Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth
COIN
1 other identifier
observational
192
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Nov 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2022
CompletedMay 31, 2023
May 1, 2023
1.4 years
October 16, 2020
May 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Term neonates
Preterm neonates
Interventions
Eligibility Criteria
Neonates immediatley after birth
You may qualify if:
- 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
You may not qualify if:
- No decision to conduct full life Support
- No written informed consent
- Congenital malformation
- Neonates who require respiratory and/ or medical support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Neonatology, Medical University of Graz
Graz, 8036, Austria
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 20, 2020
Study Start
November 13, 2020
Primary Completion
April 4, 2022
Study Completion
April 4, 2022
Last Updated
May 31, 2023
Record last verified: 2023-05