International study of cerebral oxygenation and electrical activity during major neonatal surgery

• Grant number: 25/12636-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2025
• End date: August 31, 2026
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Vinícius Caldeira Quintão
• Grantee: Samuel Pereira Levada
• Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

The study aims to collect data on cerebral oxygenation and electrical activity during major non-cardiac neonatal surgeries. To this end, it uses near-infrared spectroscopy (NIRS) to assess cerebral oxygenation and electroencephalography (EEG) to verify electrical activity. This is a prospective, observational, multicenter clinical study, with the aim of identifying the incidence of perioperative cerebral desaturation in major neonatal surgeries using non-invasive NIRS and EEG technologies. The study population consisted of pediatric patients with surgical indication for abdominal birth defects, congenital malformation of the pulmonary airways, esophageal/tracheoesophageal fistula, and spinal malformations performed at the Children and Adolescent Institute of the Hospital das Clínicas of the University of São Paulo School of Medicine (ICr-HCFMUSP). Patients included were those aged 60 weeks or younger from the date of the mother's last menstrual period on the date of surgery, who underwent surgery of interest, and who had the informed consent form signed by their guardian(s). The exclusion criteria were therefore refusal to sign the informed consent form by the guardian(s) and patients with hydrocephalus limiting frontoparietal brain volume, grade 3 or 4 interventricular hemorrhage, and malformation or cerebral infarction of the frontoparietal region. The primary outcome is to determine the incidence of perioperative desaturation using cerebral oxygenation and electrical activity values ¿¿measured, respectively, by non-invasive NIRS and EEG tools in neonatal patients undergoing major non-cardiac surgeries. Secondary outcomes are to indicate the perioperative factors associated with the occurrence of cerebral desaturation and to determine the association between perioperative cerebral desaturation and hospital/perioperative outcomes and the physiological conditions of the patients. Throughout the study, several procedures will be performed, starting with the guardian(s) of the potential patients being invited to sign the informed consent form. Patients will be monitored for cerebral oxygenation (NIRS) and electrical activity (EEG) from 1 hour before surgery until 8-24 hours after the end of surgery, and this will be done continuously from the insertion of the sensors until their removal. Perioperative outcomes, such as mechanical ventilation, cerebral infarction and cardiac arrhythmia, and physiological conditions, such as blood pressure and oxygen saturation, will also be collected from anesthetic induction up to 24 hours postoperatively, as well as hospital outcomes, such as mortality and need for tracheostomy, up to 100 days postoperatively or hospital discharge (whichever occurs first). Finally, identification, demographic data, birth history and clinical data will be collected from medical records.