Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399555
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2006-11-13
Brief Title:
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome-Correlation With Cerebral Non-invasive Infrared Spectroscopy NIRS
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs first surgery for hypoplastic left heart syndrome a monitor was placed on your childs 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
During the time of your childs first surgery for hypoplastic left heart syndrome a monitor was placed on your childs 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 Description:
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 studyhypothesis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None