Newborns with complex congenital heart defects and corrective or palliative surgery within the first six weeks of life.
Conditions
Interventions
Group 1: Foetuses and newborns with complex congenital heart defects undergoing corrective or palliative surgery (with or without cardiopulmonary bypass) within the first six weeks of life.
Sponsors
Deutsches Herzzentrum München, Uniklinikum der TUM
Eligibility
Sex/Gender
All
Age
No minimum to 6 Weeks
Inclusion criteria
Inclusion criteria: - Foetuses and newborns with complex congenital heart defects - Corrective or palliative surgery within the first six weeks of life (regardless of whether with or without cardiopulmonary bypass) - Availability of a valid declaration of consent
Exclusion criteria
Exclusion criteria: Foetuses and newborns with clinically suspected syndromic underlying disease, e.g. malformation of another organ system, or genetically confirmed syn-drome, premature babies, asphyxia or connatal infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Detection of brain maturation delays and brain pathologies postnatally, pre- and/or postoperatively; head MRIs will be performed in the first six weeks of life. - Volumetry of the various brain compartments (grey matter, white matter, cerebrospinal fluid spaces) - Children with univentricular hearts receive a second cerebral MRI at 4-6 months before the second heart operation (Stage II) under the same sedation as the cardiac catheterization in preparation for the operation - Developmental neurological outcome at 12 months of life - Collection of quality of life data | — |
Secondary
| Measure | Time frame |
|---|---|
| - Recording of risk factors for impaired development (patient-specific, clinical data, socio-economic status) | — |
Countries
Germany
Contacts
Public ContactBettina Reich
Deutsches Herzzentrum München, Uniklinikum der TUM
Outcome results
None listed