Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
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|ClinicalTrials.gov Identifier: NCT00399555|
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : November 27, 2013
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.
|Condition or disease|
|Congenital Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome—Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Patients with HLHS that have had surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001. These patients must be between the ages of 2.5 years and 6 years of age.
- To describe the developmental outcome of school-age children with HLHS who have undergone the Norwood procedure at our institution after January 1, 2001 [ Time Frame: Ages 2.5 years to 6 years ]
- Determine whether there is a correlation between cerebral oxygen levels as measured by NIRS and subsequent developmental outcome [ Time Frame: NIRS measurement 48 hours after Norwood procedure and developemental outcome by 2.5-6 years of age ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399555
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Study Director:||William Mahle, MD||Sibley Heart Center/Emory Universtiy School of Medicine|