Bloodpressure and NIRS During the Immediate Transition (RR)

October 9, 2024 updated by: Pichler Gerhard, MD., Medical University of Graz

Arterial Blood Pressure and Cerebral Tissue Oxygenation During Immediate Transition After Birth in Term and Preterm Neonates - a Prospective Pilot Observational Study

Blood pressure will be measured in min. 5/10/15 after birth. Cerebral tissue oxygenation (crSO2) monitoring with NIRS in addition to routine arterial oxygen saturation (SpO2) monitoring with pulse oximetry will be performed continuously during the first 15 minutes after birth

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

104

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, 8010
        • 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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Term and preterm neonates observed routinely at the resuscitation desk at the Division of Neonatology, Department of Pediatrics, Medical University of Graz will be eligible for the study.

Description

Inclusion Criteria:

Term and preterm neonates observed routinely immediately after birth at the resuscitation desk

  • Decision to conduct full life support
  • Written informed consent

Exclusion Criteria:

No decision to conduct full life support

  • No written informed consent
  • Congenital malformation

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
Neonates with gestational age 37+0 - 42+0 weeks
Diagnostic test: Cerebral tissue oxygenation and blood pressure measurement
Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth
Preterm neonates
Neonates with gestational age < 37+0 weeks
Diagnostic test: Cerebral tissue oxygenation and blood pressure measurement
Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 5, 10 and 15 minutes after birth
Systolic, diastolic and mean blood pressure in mmHg measured with a pneumatic cuff
5, 10 and 15 minutes after birth
Cerebral oxygenation
Time Frame: 5, 10 and 15 minutes after birth
Cerebral tissue oxygen saturation in percent measured with NIRS
5, 10 and 15 minutes after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: 5, 10 and 15 minutes after birth
Calculated out of blood pressure and heart rate
5, 10 and 15 minutes after birth

Collaborators and Investigators

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

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Gerhard Pichler, Prof, Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 27, 2022

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1026/2022 (34-221 ex 21/22)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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