Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease (CHD-NIRS)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Heart Defects, Congenital

Treatments: Other: measuring cerebral oxygenation

Study type: Observational

Funder types: Other

Identifiers

NCT01679275

S54683

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

57 participants in 1 patient group

measuring cerebral oxygenation

Description:

NIRS: Measurement of cerebral oxygenation using Near Infrared Spectroscopy (NIRS) during the pre-operative phase in neonates with congenital heart disease.

Treatment:

Other: measuring cerebral oxygenation