Blood PressureRRNCT06168045
Bloodpressure and NIRS During the Immediate Transition
An observational study of Blood Pressure and Cerebral Tissue Oxygenation, run by Medical University of Graz at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutes
- Conditions the study is for
- Blood Pressure, Cerebral Tissue Oxygenation
- What is being tested?
- Cerebral tissue oxygenation and blood pressure measurement
- How many people
- 104 participants
- Where
- 1 siteAustria
- Study dates
- 27 Jun 2022to 27 May 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 15 minutes
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Term and preterm neonates observed routinely immediately after birth at the resuscitation desk
- Decision to conduct full life support
- Written informed consent
Who cannot join
- No decision to conduct full life support
- No written informed consent
- Congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Blood Pressure and Cerebral Tissue Oxygenation During Immediate Transition After Birth in Term and Preterm Neonates - a Prospective Pilot Observational Study
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
- Being tested
- Cerebral tissue oxygenation and blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral tissue oxygenation and blood pressure measurementDiagnostic test
Measurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth
| Study group | Role | What they receive |
|---|---|---|
| Term neonates | Neonates with gestational age 37+0 - 42+0 weeks Receives: Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurement | |
| Preterm neonates | Neonates with gestational age < 37+0 weeks Receives: Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Systolic, diastolic and mean blood pressure in mmHg measured with a pneumatic cuff
Measured: 5, 10 and 15 minutes after birth
Cerebral oxygenation
Cerebral tissue oxygen saturation in percent measured with NIRS
Measured: 5, 10 and 15 minutes after birth
Secondary outcomes (1)
Cardiac output
Calculated out of blood pressure and heart rate
Measured: 5, 10 and 15 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start27 Jun 2022
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pichler Gerhard, MD., Medical University of Graz
- Investigators
- Gerhard Pichler, Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168045
- Sponsor's protocol ID
- 1026/2022 (34-221 ex 21/22)
- Acronym
- RR
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24481411Hooper 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 25671807Baik 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 at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Blood Pressure and Cerebral Tissue Oxygenation During Immediate Transition After Birth in Term and Preterm Neonates - a Prospective Pilot Observational Study
- ClinicalTrials.gov ID
- NCT06168045
- Acronym / sponsor ID
- RR / 1026/2022 (34-221 ex 21/22)
- Conditions
- Blood Pressure, Cerebral Tissue Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term neonates | – | Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurementNeonates with gestational age 37+0 - 42+0 weeks |
| Preterm neonates | – | Diagnostic Test: Cerebral tissue oxygenation and blood pressure measurementNeonates with gestational age < 37+0 weeks |
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Term and preterm neonates observed routinely immediately after birth at the resuscitation desk
- Decision to conduct full life support
- Written informed consent
Key exclusion criteria (3 listed)
- No decision to conduct full life support
- No written informed consent
- Congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral tissue oxygenation and blood pressure measurementMeasurement of cerebral tissue oxygenation with NIRS and blood pressure during immediate transition after birth | Diagnostic test | Preterm neonates, Term neonates |
Primary outcome
Blood pressure
Time frame: 5, 10 and 15 minutes after birth
Systolic, diastolic and mean blood pressure in mmHg measured with a pneumatic cuff
Cerebral oxygenation
Time frame: 5, 10 and 15 minutes after birth
Cerebral tissue oxygen saturation in percent measured with NIRS
1 secondary outcome
Cardiac output
Time frame: 5, 10 and 15 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 24481411Pichler 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.
- Background: PubMed 25671807Hooper 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.
- Background: PubMed 28427056Baik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Pichler, Prof principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Cerebral Tissue Oxygenation, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 5, 10 and 15 minutes after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168045, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.