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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07660302
Enrollment
160
Registered
2026-06-22
Start date
2026-06-17
Completion date
2029-12-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Autoregulation, General Anesthesia, Infant, Newborn, Near-infrared Spectroscopy

Brief 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. 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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 12 Months
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Presence of residual congenital heart disease * Undergoing cardiac surgery * Undergoing neurosurgery * Presence of severe brain malformation

Design outcomes

Primary

MeasureTime frame
Blood pressure limits of cerebral autoregulationFrom the start of cerebral oxygen saturation monitoring after arrival in the operating room until the end of general anesthesia, approximately 1 to 6 hours.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026