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

NCT ID: NCT04594824

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-13

Study Completion Date

2022-04-04

Brief Summary

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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

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Conditions

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Neonatal Adaptation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Term neonates

No Intervention

Intervention Type OTHER

no intervention

Preterm neonates

No Intervention

Intervention Type OTHER

no intervention

Interventions

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No Intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Minutes

Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Neonatology, Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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32-320 ex 19/2

Identifier Type: -

Identifier Source: org_study_id

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