Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William T. Mahle, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00399555
First received: November 13, 2006
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome—Correlation With Cerebral Non-invasive Infrared Spectroscopy (NIRS)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
One
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.

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 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.

  Eligibility

Ages Eligible for Study:   29 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children ages 2.5 to 6 years old who have hypoplastic left heart syndrome with surgical palliation and near infrared spectrometry monitoring during the Stage I Norwood procedure.

Criteria

Inclusion Criteria:

  1. 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
  2. Ages 2.5 to 6 years old
  3. Surgical palliation with the Norwood procedure (Stage I palliation) at Children's Healthcare of Atlanta after January 1, 2001

Exclusion Criteria:

  1. Primary language in the home is not English
  2. Named genetic syndrome associated with profound developmental delay, such as DiGeorge Syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399555

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Study Director: William Mahle, MD Sibley Heart Center/Emory Universtiy School of Medicine
  More Information

No publications provided

Responsible Party: William T. Mahle, MD, Professor of Pediatrics, Emory University
ClinicalTrials.gov Identifier: NCT00399555     History of Changes
Other Study ID Numbers: IRB00000275
Study First Received: November 13, 2006
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Single Ventricle
Hypoplastic Left Heart
Developmental

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Hypoplastic Left Heart Syndrome
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 20, 2014