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.

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Key information

Conditions

Cerebral Autoregulation General Anesthesia Infant, Newborn Near-Infrared Spectroscopy

Age range

0 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jun 22, 2026
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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