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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Site contacts updated at 1 of 15 sitesv5
  2. Primary completion date: Dec 2024 to Dec 31, 2027
    • Study completion date: Dec 2025 to Dec 31, 2027
    v4
  3. Site details revised at 2 of 15 sitesv3
  4. Study sites revised (15)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05673499
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: Masimo Corporation
Conditions
(from sponsor)		 Congenital Disorders, Cerebral Desaturation, Neonatal Surgery
Related terms Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov