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Recruiting NCT05673499

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

Conditions: Congenital Disorders, Cerebral Desaturation, Neonatal Surgery

Sex: All
Ages: N/A – 60 Weeks
Enrollment: 900
Sponsor: Children's Hospital of Philadelphia

Location: United States

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:The perioperative factors associated with occurrence of cerebral desaturationThe 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.

Eligibility Criteria

Inclusion Criteria:Infants ≤ 60 weeks post-menstrual age on day of surgery.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).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.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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05673499). StuddyBuddy aggregates publicly available trial information.