Clinical Trial

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

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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.
Trial Details
NCT Number NCT07660302
Lead Sponsor Seoul National University Hospital
Conditions Cerebral Autoregulation, Near-infrared Spectroscopy, Infant, Newborn, General Anesthesia
Enrollment 160 participants
Start Date 2026-06-17
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-22