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

Recruiting now

Conditions studied: Congenital Disorders, Cerebral Desaturation, Neonatal Surgery

In brief

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.

Key facts

Study ID

NCT05673499

Run by

Children's Hospital of Philadelphia

People needed

900

Starts

2022-08-12

Expected to finish

2027-12-31

Last updated by the study team

2026-04-23

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with hydrocephalus limiting frontal-parietal brain volume, interventricular hemorrhage (grades 3 or 4), malformation or cerebral infarction of frontal-parietal brain.

Where it is running

• Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo — São Paulo, Brazil (enrolling)
• Perth Children's Hospital — Nedlands, Australia (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Royal Children's Hospital — Parkville, Australia
• 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
• Children's Hospital at Montefiore/Albert Einstein College of Medicine — New York, New York, United States
• Great Ormond Street Hospital for Children — London, United Kingdom
• Children's Medical Center Dallas — Dallas, Texas, United States
• Children's Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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