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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04594824
Acronym
COIN
Enrollment
192
Registered
2020-10-20
Start date
2020-11-13
Completion date
2022-04-04
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Adaptation

Keywords

percentile, cerebral oxygenation, neonate, immediate after birth

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.

Interventions

OTHERNo Intervention

no intervention

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Minutes to 15 Minutes
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of cerebral tissue oxygen saturation (crSO2) levelAt each minute from minute 1 to minute 15 after birthTo 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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026