Bloodpressure and NIRS During the Immediate Transition

NCT06168045 | Completed

• 1 other identifier: 1026/2022 (34-221 ex 21/22)
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure; Cerebral Tissue Oxygenation

Outcome Measures

Primary Outcomes (2)

• Blood pressure

  Systolic, diastolic and mean blood pressure in mmHg measured with a pneumatic cuff

  5, 10 and 15 minutes after birth

• Cerebral oxygenation

  Cerebral tissue oxygen saturation in percent measured with NIRS

  5, 10 and 15 minutes after birth

Secondary Outcomes (1)

• Cardiac output

  5, 10 and 15 minutes after birth

Study Arms (2)

Term neonates

Neonates with gestational age 37+0 - 42+0 weeks

Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurement

Preterm neonates

Neonates with gestational age \< 37+0 weeks

Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurement

Interventions

Cerebral tissue oxygenation and blood pressure measurement DIAGNOSTIC_TEST

Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth

Preterm neonates; Term neonates

Eligibility Criteria

• Age: 1 Minute - 15 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Term and preterm neonates observed routinely immediately after birth at the resuscitation desk
• Decision to conduct full life support
• Written informed consent

You may not qualify if:

• No decision to conduct full life support
• No written informed consent
• Congenital malformation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

medical university of Graz

Graz, 8010, Austria

Location

Related Publications (3)

• Pichler G, Cheung PY, Aziz K, Urlesberger B, Schmolzer 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. Epub 2014 Jan 25.

  PMID: 24481411 BACKGROUND

• Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4.

  PMID: 25671807 BACKGROUND

• 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.

  PMID: 28427056 BACKGROUND

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Gerhard Pichler, Prof

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 13, 2023
• Study Start: June 27, 2022
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)