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Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

NCT00399555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2013-11-27

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • William Mahle, MD · Sibley Heart Center/Emory Universtiy School of Medicine

Eligibility

Min Age
29 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00399555 on ClinicalTrials.gov