Evaluation of biomarkers for neuronal cell injury in infants after surgery for congenital heart disease utilizing cardiopulmonary bypass - impact of cerebral tissue oxygenation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00008177

Enrollment

Registered

2015-06-05

Start date

2015-06-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery for congenital heart defects utilizing cardiopulmonary bypass in newborns and infants. Q20-Q28

Interventions

Group 1: Children with congenital heart disease undergoing surgery utilizing cardiopulmonary bypass within the first 12 months of life. Perioperative measurement of cerebral tissue Oxygen saturations

Eligibility

Sex/Gender

All

Age

No minimum to 12 Months

Inclusion criteria

Inclusion criteria: Congenital heart defect, requiring surgical repair utilizing cardiopulmonary bypass within the first 12 months of life.

Exclusion criteria

Exclusion criteria: Genetic syndrom associated with neurodevelopmental delay (proven or clinical suspicion), perinatal asphyxia, structural brain malformation, cerebral hemorrhage

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Germany

Contacts

Public ContactJan Hinnerk Hansen

Klinik für angeborene Herzfehler und Kinderkardiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel

jan.hansen@uk-sh.de0431 5971728

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026