Status:
RECRUITING
Cerebral Blood Flow in Neonates During Major Cardiac Surgery.
Lead Sponsor:
UMC Utrecht
Conditions:
Hypoperfusion in Newborn With Congenital Heart Disease
Eligibility:
All Genders
Up to 6 years
Brief Summary
Rationale: During cardiac surgery, neonates are at high risk of cerebral damage: 36-78% will have new cerebral lesions after surgery. Adequate cerebral perfusion (CBF) is mandatory to prevent postoper...
Eligibility Criteria
Inclusion
- Term infant aged \< 42 days / Preterm born \> 32 weeks and with a corrected age \< 42 days
- (Semi-) elective cardiac of major non-cardiac surgery
- Routine placement of an arterial cannula for invasive blood pressure monitoring.
Exclusion
- Grade III-IV intracranial hemorrhage.
- Emergency surgery or semi-elective surgery performed out of hours.
- Informed consent from the parents is not obtained.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04713605
Start Date
March 23 2022
End Date
January 1 2026
Last Update
March 27 2024
Active Locations (1)
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1
UMC Utrecht / Wilhelmina Children's Hospital
Utrecht, Netherlands, 3508GA