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Congenital heart disease with need for early surgery in newborns is associated with an increased incidence in global impairment in development. The causes of these late adverse neurologic outcomes are multifactoral and include both fixed (or patient-specific factors) and modifiable factors. They relate to both the mechanism of central nervous system injury associated with congenital heart disease and its treatment. Measuring cerebral oxygenation is a promising non-invasive way of cerebral monitoring in a neonatal intensive care unit. The importance of cerebral monitoring in neonates with congenital heart problems at risk of developing neurological complications is increasingly recognized. In this way the most vulnerable moments for the newborn brain can be detected and ,if possible, lead to change in (timing of) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| measuring cerebral oxygenation | NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measuring cerebral oxygenation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopmental follow up at 24 months | Neurodevelopmental assessment at 24 months using Bayley scales of infant development II | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| cerebrovascular changes in the transitional phase | Cerebral oxygen saturation and autoregulatory capacity | first 3 days of life |
| Association of cerebrovascular changes with short term outcome | short term outcome defined as cerebral ultrasound abnormalities at admission and discharge, ICU stay, hospital stay and mortality before discharge |
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Inclusion Criteria:
Exclusion Criteria:
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infants with congenital heart defect
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| Name | Affiliation | Role |
|---|---|---|
| Liesbeth Thewissen, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit UZLeuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2023 | |
| Reset | Jan 11, 2024 | |
| Release | Jul 29, 2024 | |
| Reset | Oct 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2023 | Jan 11, 2024 | |||
| Jul 29, 2024 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| time frame of 1 admission |
| Oct 17, 2024 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |