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CompletedNCT06168045RRUpdated Oct 10, 2024

Bloodpressure and NIRS During the Immediate Transition

An observational study in Blood Pressure and Cerebral Tissue Oxygenation, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 1 Minute to 15 Minutes. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
104
Ages
1 Minute to 15 Minutes
Sex
All
01

Study 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

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Conditions studied

  • Blood Pressure
  • Cerebral Tissue Oxygenation
03

In context

Lead sponsor

Medical University of Graz is the lead sponsor of 470 studies on the registry; 98 are open to participants now.

Browse Medical University of Graz studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Minute to 15 Minutes
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

No decision to conduct full life support

  • No written informed consent
  • Congenital malformation
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
104 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testCerebral tissue oxygenation and blood pressure measurement

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

06

What researchers measure

Primary outcomes

  1. Blood pressure

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

    Time frame: 5, 10 and 15 minutes after birth

  2. Cerebral oxygenation

    Cerebral tissue oxygen saturation in percent measured with NIRS

    Time frame: 5, 10 and 15 minutes after birth

Secondary outcomes

  1. Cardiac output

    Calculated out of blood pressure and heart rate

    Time frame: 5, 10 and 15 minutes after birth

07

Study locations

1 site
  • medical university of Graz
    Graz, 8010, Austria
08

References and documents

Publications

  • 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. PubMed 24481411 ↗
  • 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. PubMed 25671807 ↗
  • 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. PubMed 28427056 ↗

Study documents

  • Protocol and statistical analysis plan · May 5, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2022 to primary completion in May 2024, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2023
First posted
Dec 13, 2023
StartActual
Jun 27, 2022
Primary completionActual
May 27, 2024
CompletionActual
May 27, 2024
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06168045
Lead sponsor
Medical University of Graz
Responsible party
Pichler Gerhard, MD. (Prof, Medical University of Graz) — Principal investigator
First posted
Dec 13, 2023
Start date
Jun 27, 2022
Primary completion
May 27, 2024
Completion
May 27, 2024
Last update
Oct 10, 2024

Study contacts

Gerhard Pichler, Prof
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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