Home › and Neonatal Diseases and Abnormalities Hereditary Congenital › NCT05673499

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

Who can join

60 Weeks · All sexes

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.

About the study

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.

What is being tested

• NIRS/EEG monitoring (device)

Sponsor: Children's Hospital of Philadelphia · Participants: 900 · Started: Aug 12, 2022

Contact the study team

• Paula Hu, RN, MSPH · Phone: 267-426-2961
• Elizabeth Ramsay · Phone: 267-270-5087

Official record on ClinicalTrials.gov — NCT05673499

Locations in the U.S.

Conditions

• and Neonatal Diseases and Abnormalities Hereditary Congenital

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.