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Clinical Trials/NCT01679275
NCT01679275
Completed
Not Applicable

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

Universitaire Ziekenhuizen KU Leuven1 site in 1 country57 target enrollmentOctober 2012

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
June 2018
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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