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

May 30, 2023 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Division of Neonatology, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 15 minutes (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Neonates immediatley after birth

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Term neonates
Other: No Intervention
no intervention
Preterm neonates
Other: No Intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of cerebral tissue oxygen saturation (crSO2) level
Time Frame: 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.
At each minute from minute 1 to minute 15 after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2020

Primary Completion (Actual)

April 4, 2022

Study Completion (Actual)

April 4, 2022

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 32-320 ex 19/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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