NCT01679275

Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease

Longitudinal Pre-operative Measurements of Cerebral Oxygenation Using Near Infrared Spectroscopy in Neonates With Congenital Heart Disease.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 57 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital

Interventions

Type	Name	Description
OTHER	measuring cerebral oxygenation

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2012-09-05
• Last updated: 2023-01-30

Locations

1 site across 1 country: Belgium