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ACTIVE NOT RECRUITING
NCT07660302

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Days - 12 Months

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-06-17

Completion Date

2029-12-31

Last Updated

2026-06-22

Healthy Volunteers

No

Locations (1)

Seoul National University Hospital

Seoul, South Korea