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Clinical Trial 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.


Clinical Trial Description

The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis. Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted: - Respiratory record - Post-op recovery, ICU, and discharge records - Cardiac and Neurologic records - Neurologic test such as radiology and lab tests - Mortality status ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05673499
Study type Observational
Source Children's Hospital of Philadelphia
Contact Paula Hu, RN, MSPH
Phone 267-426-2961
Email hup@chop.edu
Status Recruiting
Phase
Start date August 12, 2022
Completion date December 2025

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