International Study of Cerebral Oxygenation and Electrical Activity During Major Neonatal Surgery
Recruiting
Observational Study
Congenital Disorders
Cerebral Desaturation
Neonatal Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- Up to 60 Weeks
- Sex
- Any
- Study type
- Observational
- Participants needed
- 900 (estimated)
- Sponsor
- Children's Hospital of Philadelphia · Other
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About This Trial
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 physiolo…
Trial Locations
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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), co…
Contacts