International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Start Date
8/12/2022
Completion Date
12/31/2027
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.
Detailed 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
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
NIRS/EEG monitoring
Conditions
Locations
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, New York 10467
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Children's Medical Center Dallas
Dallas, Texas 75235
United States
Children's Memorial Hermann Hospital
Houston, Texas 77030
United States
Perth Children's Hospital
Nedlands,
Australia
Royal Children's Hospital
Parkville,
Australia
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo,
Brazil
Guangzhou women and children's medical center
Guangzhou,
China
Shanghai Children's Medical Center
Shanghai,
China
Shengjing Hospital of China Medical University
Shenyang,
China
West China Hospital and West China Second University Hospital
Sichuan,
China
Centre Hospitalier Universitaire de Bordeaux, Hopital des enfants
Bordeaux,
France
Post Graduate Institute of Medical Education and Research
Chandigarh,
India
Christian Medical College Hospital
Vellore,
India
Great Ormond Street Hospital for Children
London,
United Kingdom