Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
Completed
Conditions studied: Congenital Heart Disease
In brief
There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome. During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. This monitor is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. The researchers plan to enroll 60 research subjects.
Key facts
- Study ID
- NCT00399555
- Run by
- Emory University
- People needed
- 28
- Starts
- 2006-11-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2013-11-27
Who can join
Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hypoplastic left heart syndrome is defined as normal segmental anatomy with mitral and/or aortic atresia or stenosis and a left ventricle too small to sustain the systemic circulation
- Ages 2.5 to 6 years old
- Surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001
You may not qualify if…
- Primary language in the home is not English
- Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome
Where it is running
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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