Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes

Completed

Conditions studied: Hypoplastic Left Heart Syndrome

In brief

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 have an impact on development. Studying how post-operative condition impacts outcomes may help us to protect babies better when they undergo surgery. This study will look at some of the long-term outcomes of children with HLHS, including both mental development and quality of life. We will use information from your child's medical record to see if early oxygen delivery has an impact on later development.

Key facts

Study ID

NCT00464100

Run by

Medical College of Wisconsin

People needed

48

Starts

2006-03-01

Expected to finish

2013-12-04

Last updated by the study team

2019-08-15

Who can join

Age: 4 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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