Bloodpressure and NIRS During the Immediate Transition

Completed

• Conditions: Cerebral Tissue Oxygenation; Blood Pressure

• Registration Number: NCT06168045
• Lead Sponsor: Medical University of Graz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-27
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-13
• Primary Completion: 2024-05-27
• Study Completion: 2024-05-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiac output	5, 10 and 15 minutes after birth	Calculated out of blood pressure and heart rate

Trial Locations

Locations (1)

medical university of Graz; 🇦🇹 Graz, Austria