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

NCT07660302 | Active Not Recruiting

• 1 other identifier: H2602-079-1717
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

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

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

KR (1)