Status:
NOT_YET_RECRUITING
Brain Autoregulation Research Study
Lead Sponsor:
Bradley Marino
Conditions:
Hypotension During Surgery
Hypotension Postprocedural
Eligibility:
All Genders
30-30 years
Phase:
NA
Brief Summary
Randomized, multi-site, study assessing the feasibility of lower limit of autoregulation targeted mean arterial pressure (MAP) vs. standard MAP management in neonates undergoing cardiac surgery with c...
Detailed Description
Congenital heart disease (CHD) is the most common birth defect.1 Surgery to treat CHD is complicated by white matter injury (WMI) on brain magnetic resonance imaging (MRI) and neurodevelopmental (ND) ...
Eligibility Criteria
Inclusion
- All neonates (\<30 days of age)
- Undergoing cardiothoracic surgery with cardiopulmonary bypass
Exclusion
- Less than full term (\<37 weeks gestation)
- Weight \< 2.50kg
- Genetic abnormality or syndrome except heterotaxy syndrome
- Major non-cardiac anomalies (e.g. congenital diaphragmatic hernia, - omphalocele, holoprosencephaly, anencephaly)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT07221721
Start Date
November 1 2025
End Date
December 1 2028
Last Update
October 30 2025
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195