Clinical Trial: Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome—Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)
Brief Summary:
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.
Detailed Summary: Our study is a cross-sectional, descriptive study to evaluate the developmental outcome for school-age children with HLHS. The general approach of the proposed research is confirmatory study/hypothesis testing. The hypothesis (neurodevelopmental outcome of children with HLHS is inversely correlated with cerebral oximetry values as measured by NIRS in the 48 hours following the Norwood operation) was formulated based on a meticulous review of the literature, which clearly demonstrates a substantial prevalence of neurodevelopmental deficits in children with HLHS who have undergone surgical palliation. The methodologies for measuring developmental outcome are highly reproducible and have been validated in this population.
Sponsor: Emory University
Current Primary Outcome: 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 ]
Original Primary Outcome:
Current Secondary Outcome: 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 ]
Original Secondary Outcome:
Information By: Emory University
Dates:
Date Received: November 13, 2006
Date Started: November 2006
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013
