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International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

NCT05673499 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2026-04-23

No results posted yet for this study

Summary

The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:

1. The perioperative factors associated with occurrence of cerebral desaturation
2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.

Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.

Conditions

  • Congenital Disorders
  • Cerebral Desaturation
  • Neonatal Surgery

Interventions

DEVICE

NIRS/EEG monitoring

The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.

Sponsors & Collaborators

Principal Investigators

  • Charles Dean Kurth, MD · Children's Hospital of Philadelphia

Eligibility

Max Age
60 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States
  • Australia
  • Brazil
  • China
  • France
  • India
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05673499 on ClinicalTrials.gov