Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes

NCT00464100 | Completed

• 1 other identifier: CHW 06/36
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may have an impact on development. Studying how post-operative condition impacts outcomes may help us to protect babies better when they undergo surgery. This study will look at some of the long-term outcomes of children with HLHS, including both mental development and quality of life. We will use information from your child's medical record to see if early oxygen delivery has an impact on later development.

Conditions

Hypoplastic Left Heart Syndrome

Keywords

Neurodevelopmental outcomes; congenital heart disease; NIRS monitoring; hypoxia

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Cases: * clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent Controls: Healthy children 4-5 years old, English-speaking patient and parent, informed consent

You may qualify if:

• Cases:
• clinical diagnosis of hypoplastic left heart syndrome, status post Norwood procedure, bidirectional Glenn, and completion Fontan, ages 4-5 years old, English-speaking patient and parent, informed consent
• Controls:
• Healthy children 4-5 years old, English-speaking patient and parent, informed consent

You may not qualify if:

• Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome; Heart Defects, Congenital; Hypoxia

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Ghanayem, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pediatrics, Critical Care

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: March 1, 2006
• Primary Completion: December 4, 2013
• Study Completion: December 4, 2013
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)