Status:
COMPLETED
Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Children's Hospital and Health System Foundation, Wisconsin
Conditions:
Hypoplastic Left Heart Syndrome
Eligibility:
All Genders
4-5 years
Brief Summary
We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may hav...
Detailed Description
Over the past twenty years, the field of congenital heart disease has been marked by globally improved survival after complex congenital heart surgery. These improved results are clearly multi-factori...
Eligibility Criteria
Inclusion
- Cases:
- clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent
- Controls:
- Healthy children 4-5 years old, English-speaking patient and parent, informed consent
Exclusion
- Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 4 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00464100
Start Date
March 1 2006
End Date
December 4 2013
Last Update
August 15 2019
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226