Cerebral OxygenationNCT04132414
Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants
A study testing NIRS open in people with Cerebral Oxygenation, run by Medical University of Graz.
Trial summary
The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Cerebral Oxygenation
- What is being tested?
- NIRS open
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2023
- Phase
- Interventional
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Expected duration of Anesthesia >45 minutes
- Intervention/surgery in the operating room
Who cannot join
- Impossibility to place cerebral NIRS sensor
- Known cerebral pathology
- Missing parental consent
- Congenial cardiac condition with right to left shunt
- Cardiac surgery
About this study
Official title: Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management
The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.
- Conditions
- Cerebral Oxygenation
- Being tested
- NIRS open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS openDiagnostic test
Treatment according to protocol in phases of cerebral hypoxia.
| Study group | Role | What they receive |
|---|---|---|
| NIRS open | Experimental | Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia Receives: Diagnostic Test: NIRS open |
| NIRS blinded | No intervention | NIRS monitoring applied and masked for caregiver. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral hypoxic burden
Time under 65% cerebral oxygen saturation
Measured: 1 day
Secondary outcomes (4)
Fluid administration
ml/kg
Measured: 1 day
Number of participants with Vasopressor or Inotrope administered
Proportion
Measured: 1 day
Number of participants with erythrocyte administration
Proportion
Measured: 1 day
Fraction of inspired oxygen
%
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study startDec 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study investigators changed institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral OxygenationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Heschl, M.D., Ph.D., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132414
- Sponsor's protocol ID
- 31-175 ex 18/19
- Status last verified
- May 2025
- First submitted
- 5 Sep 2019
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management
- ClinicalTrials.gov ID
- NCT04132414
- Acronym / sponsor ID
- 31-175 ex 18/19
- Conditions
- Cerebral Oxygenation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study investigators changed institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Oct 2019 (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.
The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIRS open | Experimental | Diagnostic Test: NIRS openCerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia |
| NIRS blinded | No intervention | –NIRS monitoring applied and masked for caregiver. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Expected duration of Anesthesia >45 minutes
- Intervention/surgery in the operating room
Key exclusion criteria (5 listed)
- Impossibility to place cerebral NIRS sensor
- Known cerebral pathology
- Missing parental consent
- Congenial cardiac condition with right to left shunt
- Cardiac surgery
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 |
|---|---|---|
| NIRS openTreatment according to protocol in phases of cerebral hypoxia. | Diagnostic test | NIRS open |
Primary outcome
Cerebral hypoxic burden
Time frame: 1 day
Time under 65% cerebral oxygen saturation
4 secondary outcomes
Fluid administration
Time frame: 1 day
Number of participants with Vasopressor or Inotrope administered
Time frame: 1 day
Number of participants with erythrocyte administration
Time frame: 1 day
Fraction of inspired oxygen
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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.
Stefan Heschl, M.D., Ph.D. principal investigator
Medical University of Graz
Questions about this trial
What is this clinical trial studying?
A study testing NIRS open in people with Cerebral Oxygenation, run by Medical University of Graz.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Cerebral hypoxic burden (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.