Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

NCT00399555 | Completed

• 1 other identifier: IRB00000275
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Single Ventricle; Hypoplastic Left Heart; Developmental

Outcome Measures

Primary Outcomes (1)

• To describe the developmental outcome of school-age children with HLHS who have undergone the Norwood procedure at our institution after January 1, 2001

  Ages 2.5 years to 6 years

Secondary Outcomes (1)

• Determine whether there is a correlation between cerebral oxygen levels as measured by NIRS and subsequent developmental outcome

  NIRS measurement 48 hours after Norwood procedure and developemental outcome by 2.5-6 years of age

Study Arms (1)

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.

Eligibility Criteria

• Age: 29 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart; Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• William Mahle, MD

  Sibley Heart Center/Emory Universtiy School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)