Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Defects, Congenital
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Neurodevelopmental follow up at 24 months
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •neonates with admission on neonatal intensive care unit with congenital heart disease.
Exclusion Criteria
- •No informed consent. (for the long term neurodevelopmental FU)
- •no cerebral oxygen saturation in the first 3 day's of life
- •gestational age \< 37 weeks
Outcomes
Primary Outcomes
Neurodevelopmental follow up at 24 months
Time Frame: 24 months
Neurodevelopmental assessment at 24 months using Bayley scales of infant development II
Secondary Outcomes
- Association of cerebrovascular changes with short term outcome(time frame of 1 admission)
- cerebrovascular changes in the transitional phase(first 3 days of life)