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.
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 Type
OBSERVATIONAL
Enrollment
900
The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, New York, United States
NOT_YET_RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGChildren's Medical Center Dallas
Dallas, Texas, United States
NOT_YET_RECRUITINGChildren's Memorial Hermann Hospital
Houston, Texas, United States
NOT_YET_RECRUITINGPerth Children's Hospital
Nedlands, Australia
RECRUITINGRoyal Children's Hospital
Parkville, Australia
NOT_YET_RECRUITINGHospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo, Brazil
RECRUITINGGuangzhou women and children's medical center
Guangzhou, China
NOT_YET_RECRUITINGShanghai Children's Medical Center
Shanghai, China
NOT_YET_RECRUITINGShengjing Hospital of China Medical University
Shenyang, China
NOT_YET_RECRUITING...and 5 more locations
Percentage of participants with perioperative cerebral desaturation
The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of \<70% and/or \>10% decrease from baseline for \> 3 minutes
Time frame: 24 hours
Isoelectric EEG
Determined by EEG amplitude ≤ 10mV for ≥ 2 secs
Time frame: up to 24 hours
Perioperative outcomes
Medical record review
Time frame: up to 100 days
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