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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06168045
Other study ID # 1026/2022 (34-221 ex 21/22)
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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