Bloodpressure and NIRS During the Immediate Transition

Blood Pressure Clinical Trial

— RR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168045
• Other study ID #: 1026/2022 (34-221 ex 21/22)
• Status: Recruiting
• Start date: June 27, 2022
• Est. completion date: June 27, 2024

Study information

• Verified date: December 2023
• Source: Medical University of Graz
• Contact: Daniel Pfurtscheller, Dr
• Phone: 06804053233
• Email: Daniel.pfurtscheller[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 27, 2024
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 15 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cerebral Tissue Oxygenation

Intervention

Diagnostic Test:
• Cerebral tissue oxygenation and blood pressure measurement
Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

Locations

Country	Name	City	State
Austria	medical university of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (3)

Baik N, Urlesberger B, Schwaberger B, Avian A, Mileder L, Schmolzer GM, Pichler G. Blood Pressure during the Immediate Neonatal Transition: Is the Mean Arterial Blood Pressure Relevant for the Cerebral Regional Oxygenation? Neonatology. 2017;112(2):97-102. doi: 10.1159/000455965. Epub 2017 Apr 21. — View Citation

Hooper SB, te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M et al. Cardiovascular transition at birth: A physiological sequence. Pediatr Res 2015; 77(5):608-14. doi: 10.1038/pr.2015.21.

Pichler G, Cheung P-Y, Aziz K, Urlesberger B, Schmölzer GM. How to Monitor the Brain during Immediate Neonatal Transition and Resuscitation: A Systematic Qualitative Review of the Literature. Neonatology 2014; 105(3):205-10. doi: 10.1159/000357162

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Systolic, diastolic and mean blood pressure in mmHg measured with a pneumatic cuff	5, 10 and 15 minutes after birth
Primary	Cerebral oxygenation	Cerebral tissue oxygen saturation in percent measured with NIRS	5, 10 and 15 minutes after birth
Secondary	Cardiac output	Calculated out of blood pressure and heart rate	5, 10 and 15 minutes after birth