Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome Univentricular Heart

Age range

29 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Primary language in the home is not English
Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome-Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Nov 15, 2006
Registry last updated: Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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