Cerebral AutoregulationNCT07660302
Determination of Blood Pressure Limit of Cerebral Autoregulation During Non-cardiac Surgery in Preterm Infants, Neonates and Term Infants: a Prospective Observational Study Using Near-infrared Spectroscopy Monitoring
An observational study of Cerebral Autoregulation and Near-infrared Spectroscopy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective observational study aims to determine the blood pressure range in which cerebral autoregulation is maintained in preterm neonates, preterm infants, term neonates, and term infants undergoing non-cardiac surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 0 days to 12 months
- Conditions the study is for
- Cerebral Autoregulation, Near-infrared Spectroscopy, Infant, Newborn
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 days to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm and term neonates and infants aged 0 days to 12 months undergoing non-cardiac surgery under general anesthesia for 60 minutes or longer at Seoul National University Children's Hospital.
Who may be able to join
- Pediatric patients undergoing non-cardiac surgery under general anesthesia Expected duration of anesthesia of 60 minutes or longer
- Patients who meet one of the following age criteria:
- Preterm neonates: born at <37 weeks of gestation and ≤1 month of postnatal age Preterm infants: born at <37 weeks of gestation and 1-12 months of postnatal age Term neonates: born at ≥37 weeks of gestation and ≤1 month of postnatal age Term infants: born at ≥37 weeks of gestation and 1-12 months of postnatal age Written informed consent obtained from a parent or legal guardian
Who cannot join
- Presence of residual congenital heart disease
- Undergoing cardiac surgery
- Undergoing neurosurgery
- Presence of severe brain malformation
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational study aims to determine the blood pressure range in which cerebral autoregulation is maintained in preterm neonates, preterm infants, term neonates, and term infants undergoing non-cardiac surgery under general anesthesia. Cerebral autoregulation will be assessed using the cerebral oximetry index, calculated from mean arterial pressure and regional cerebral oxygen saturation measured by near-infrared spectroscopy.
A total of 160 patients, 40 in each age group, will be enrolled. The lower limit of autoregulation, optimal mean arterial pressure, and upper limit of autoregulation will be estimated for each patient and compared across age groups. The results may help support age-specific intraoperative blood pressure management in vulnerable pediatric patients.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm neonates | born before 37 weeks' gestation, ≤1 month of age | |
| Preterm infants | born before 37 weeks' gestation, 1-12 months of age | |
| Term neonates | born at ≥37 weeks' gestation, ≤1 month of age | |
| Term infants | born at ≥37 weeks' gestation, 1-12 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure limits of cerebral autoregulation
Measured: From the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start17 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AutoregulationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660302
- Sponsor's protocol ID
- H2602-079-1717
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Blood Pressure Limit of Cerebral Autoregulation During Non-cardiac Surgery in Preterm Infants, Neonates and Term Infants: a Prospective Observational Study Using Near-infrared Spectroscopy Monitoring
- ClinicalTrials.gov ID
- NCT07660302
- Acronym / sponsor ID
- H2602-079-1717
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jun 2026 (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.
This prospective observational study aims to determine the blood pressure range in which cerebral autoregulation is maintained in preterm neonates, preterm infants, term neonates, and term infants undergoing non-cardiac surgery under general anesthesia. Cerebral autoregulation will be assessed using the cerebral oximetry index, calculated from mean arterial pressure and regional cerebral oxygen saturation measured by near-infrared spectroscopy.
A total of 160 patients, 40 in each age group, will be enrolled. The lower limit of autoregulation, optimal mean arterial pressure, and upper limit of autoregulation will be estimated for each patient and compared across age groups. The results may help support age-specific intraoperative blood pressure management in vulnerable pediatric patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates | – | –born before 37 weeks' gestation, ≤1 month of age |
| Preterm infants | – | –born before 37 weeks' gestation, 1-12 months of age |
| Term neonates | – | –born at ≥37 weeks' gestation, ≤1 month of age |
| Term infants | – | –born at ≥37 weeks' gestation, 1-12 months of age |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm and term neonates and infants aged 0 days to 12 months undergoing non-cardiac surgery under general anesthesia for 60 minutes or longer at Seoul National University Children's Hospital.
Key inclusion criteria (3 listed)
- Pediatric patients undergoing non-cardiac surgery under general anesthesia Expected duration of anesthesia of 60 minutes or longer
- Preterm neonates: born at <37 weeks of gestation and ≤1 month of postnatal age Preterm infants: born at <37 weeks of gestation and 1-12 months of postnatal age Term neonates: born at ≥37 weeks of gestation and ≤1 month of postnatal age Term infants: born at ≥37 weeks of gestation and 1-12 months of postnatal age Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (4 listed)
- Presence of residual congenital heart disease
- Undergoing cardiac surgery
- Undergoing neurosurgery
- Presence of severe brain malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood pressure limits of cerebral autoregulation
Time frame: From the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Homeostasis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cerebral Autoregulation and Near-infrared Spectroscopy, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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 limits of cerebral autoregulation (time frame: From the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.). 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 22 Jun 2026.