Evaluation of biomarkers for neuronal cell injury in infants after surgery for congenital heart disease utilizing cardiopulmonary bypass - impact of cerebral tissue oxygenation.
Not Applicable
- Conditions
- Surgery for congenital heart defects utilizing cardiopulmonary bypass in newborns and infants.Q20-Q28Congenital malformations of the circulatory system
- Registration Number
- DRKS00008177
- Lead Sponsor
- Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Congenital heart defect, requiring surgical repair utilizing cardiopulmonary bypass within the first 12 months of life.
Exclusion Criteria
Genetic syndrom associated with neurodevelopmental delay (proven or clinical suspicion), perinatal asphyxia, structural brain malformation, cerebral hemorrhage
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum serum level of S100B and GFAP within the first 48 postoperative hours (blood draws at 0, 12, 24 and 48 hours after surgery) and perioperative cerebral tissue oxygenation obtained by NIRS. Evaluation of neurodevelopmental outcome at 24-36 months of age with Bayley-Scales of Infant Development.
- Secondary Outcome Measures
Name Time Method