International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Children's Hospital of Philadelphia
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.
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 downloade…
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. Infants ≤ 60 weeks post-menstrual age on day of surgery. 2. Neonatal surgery for congenital abdominal/gastrointestinal malformations (diaphragmatic hernia, gastroschisis, omphalocele, intestinal atresia, Hirschsprung's disease, imperforate anus, necrotizing enterocolitis), congenital cystic adenomatoid/pulmonary airway malformation (CCAM/CPAM), esophageal/tracheoesophageal fistula (EF/TEF), and spinal malformations (myelomeningocele, sacrococcygeal teratoma). 3. The same patient may be enrolled multiple times for repeat or different procedures that meet the above criter…
Interventions
- DeviceNIRS/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.
Locations (15)
- Children's Hospital at Montefiore/Albert Einstein College of MedicineNew York, New York
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Children's Medical Center DallasDallas, Texas
- Children's Memorial Hermann HospitalHouston, Texas
- Perth Children's HospitalNedlands
- Royal Children's HospitalParkville