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

Recruitingn/aAges any - 60 WeeksAllChildren's Hospital of Philadelphia
NCT05673499 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • NIRS/EEG monitoring
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Where

15 sites
Children's Hospital at Montefiore/Albert Einstein College of Medicine
New York, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Children's Medical Center Dallas
Dallas, United States
Children's Memorial Hermann Hospital
Houston, United States
Perth Children's Hospital
Nedlands, Australia
Royal Children's Hospital
Parkville, Australia
Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
São Paulo, Brazil
Guangzhou women and children's medical center
Guangzhou, China

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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