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Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes (NIRS ND)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Nancy Ghanayem, Medical College of Wisconsin.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464100
First Posted: April 20, 2007
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Nancy Ghanayem, Medical College of Wisconsin
  Purpose

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.


Condition
Hypoplastic Left Heart Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurodevelopmental Outcomes and Postoperative Hemodynamics in Children With Hypoplastic Left Heart Syndrome

Resource links provided by NLM:


Further study details as provided by Nancy Ghanayem, Medical College of Wisconsin:

Estimated Enrollment: 48
Study Start Date: August 2006
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Over the past twenty years, the field of congenital heart disease has been marked by globally improved survival after complex congenital heart surgery. These improved results are clearly multi-factorial and include advances in diagnostic technologies, surgical techniques, perfusion strategies, pharmacologic therapies and perioperative monitoring of tissue oxygen delivery.

Hypoplastic left heart syndrome (HLHS) represents an extreme form of complex congenital heart disease in which the infant has prolonged cyanosis and a single systemic right ventricle. Staged palliation beginning with surgery in the neonatal period is the most common approach to infants with HLHS. After initial surgical palliation, infants are critically ill due to ischemia/reperfusion injury from cardiopulmonary bypass, coronary ischemia attributed to diastolic runoff, reduced total ventricular mass, continued hypoxemia during a time of increased metabolic demands, and finally, the inherent inefficiency of parallel circulation. The presence of any one of these physiologic derangements places the infant with HLHS at great risk for ischemia, organ dysfunction, circulatory collapse and, even, death. Postoperative monitoring of venous oximetry and, more recently, near infrared spectroscopy, have identified periods of impaired oxygen delivery and ischemia, allowed for interventions that enhance oxygen delivery and improved survival after cardiac surgery. Although, an apparent relationship exists between oxygen delivery and survival after cardiac surgery, little data is available on the relationship between oxygen delivery and neurodevelopmental outcomes (inclusive of neurocognitive and neuropsychologic outcomes).

Preliminary data from our center has recently identified that reduced venous oximetry was associated with adverse neurodevelopmental outcome. These initial findings warrant further investigation of neurologic injury, specifically, how such morbidity relates to perioperative ischemia and cerebral oxygen delivery. Hence, the purpose of this study is to understand the relationship of perioperative tissue dysoxia and long-term neurodevelopmental morbidity in children subject to oxygen delivery at which neurodevelopment is compromised. Identification of a critical threshold that may be devastating to a child's neurodevelopment and quality of life would allow for early intervention, goal-directed therapy and ultimately, improve outcomes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital or acquired abnormality associated with neurologic morbidity independent of cardiac lesion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464100


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Nancy Ghanayem, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

Responsible Party: Nancy Ghanayem, Associate Professor, Pediatrics, Critical Care, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00464100     History of Changes
Other Study ID Numbers: CHW 06/36
First Submitted: April 18, 2007
First Posted: April 20, 2007
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Nancy Ghanayem, Medical College of Wisconsin:
Neurodevelopmental outcomes
congenital heart disease
NIRS monitoring
hypoxia

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