International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Dec 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying brain oxygen levels and electrical activity in newborns who are undergoing major surgery for birth defects. The researchers want to find out how often babies experience a drop in brain oxygen levels during surgery and what factors might contribute to this. They will also look at how these changes in brain oxygen relate to the babies' overall health and recovery after surgery.

To participate in this study, infants must be 60 weeks or younger in terms of their development and scheduled for surgery related to specific congenital conditions, such as issues with the intestines or lungs. Parents or guardians will need to give permission for their child to join. During the trial, babies will be monitored using special equipment to measure brain activity and oxygen levels for about an hour before surgery, throughout the surgery, and for up to 24 hours afterward. This research aims to improve understanding and care for newborns undergoing these important procedures.

Gender

ALL

Eligibility criteria

• 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 criteria. These subjects will be counted more than once towards the enrollment goal.
• • 4. Parental/guardian permission.
• Exclusion Criteria:
• • 1) Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.