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

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 Overview

• Status: Active, not recruiting
• Conditions: General Anesthesia; Cerebral Autoregulation; Infant, Newborn; Near-infrared Spectroscopy

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood pressure limits of cerebral autoregulation	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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: H2602-079-1717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No