Prospective Analysis of Cerebral Perfusion Using Head Ultrasound and Multi-source-detector Near Infrared Spectroscopy (NIRS) Imaging

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Texas Southwestern Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The University of Texas at Arlington
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01082536
First received: March 5, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

The purpose of this study is to use an experimental diagnostic tool(NIRS), combined with a known screening tool (cranial ultrasound), to analyze and evaluate cerebral blood flow and oxygenation, and determine if abnormal neurodevelopmental outcomes can be predicted and potentially improved upon in pediatric patients undergoing repair for congenital heart disease.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Analysis of Regional Cerebral Perfusion Using Head Ultrasound and Multi-source-detector Near Infrared Spectroscopy (NIRS) Imaging

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To determine if the use of cranial ultrasound and multi-source-detector near infrared spectroscopy can identify alterations in cerebral perfusion that are associated with long-term neurologic dysfunction. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Using multi-channel NIRS and pre-, intra-, and post-operative ultrasound, we will measure blood oxygenation levels and try to correlate these levels with 12 month neuropsychological evaluation.


Secondary Outcome Measures:
  • 2. Evaluate whether changes in resistive indices as determined by cranial ultrasound after cardiopulmonary bypass are associated with major neurologic dysfunction. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 3. Describe regional changes in brain tissue oxygenation during selective cerebral perfusion using near-infrared spectroscopy and determine if there are critical thresholds that correlate with poor neurologic outcomes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To accomplish this, we will describe differences in cerebral blood flow and oxygenation as related to structural anatomy of the heart. Specifically, we will compare single ventricle and two ventricle hearts with regards to use of cardiopulmonary bypass with or without selective cerebral perfusion. We will also determine if a prolonged reduction in cerebral oxygenation intraoperatively is associated with ultrasound-diagnosed periventricular leukomalacia at discharge.


Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 70
Study Start Date: May 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
One ventricle pts, bypass, perfusion
1. Single ventricle patients who undergo cardiopulmonary bypass and selective cerebral perfusion.
One ventricle pts, bypass only
Single ventricle patients who undergo cardiopulmonary bypass but not selective cerebral perfusion
One ventricle pts, no bypass/perfusion
Single ventricle patients who undergo surgery, but do not undergo cardiopulmonary bypass or selective cerebral perfusion.
Two ventricle pts, bypass, perfusion
Two ventricle patients who undergo cardiopulmonary bypass and selective cerebral perfusion.
Two ventricle pts, bypass only
Two ventricle patients who undergo cardiopulmonary bypass but not selective cerebral perfusion.
Two ventricle pts, no bypass/perfusion
Two ventricle patients who do not undergo cardiopulmonary bypass or selective cerebral perfusion.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infants (up to 2 months) with congenital heart disease that undergo surgery at Children's Medical Center Dallas (CMCD) will be eligible. All such patients will receive standard pre-, intra-, and post-operative care.

Criteria

Inclusion Criteria:

  1. Is less than 2 months of age
  2. Has congenital heart disease requiring surgical repair.
  3. All racial and ethnic groups will be eligible. Both genders are eligible.
  4. Spanish-speaking subjects are eligible.

Exclusion Criteria:

  • Patients with known genetic syndromes will be excluded from the study.
  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: NCT01082536

Contacts
Contact: Joshua Koch, MD 214-456-0441 josh.koch@childrens.com
Contact: Steven Kernie, MD 214-648-4183 steven.kernie@utsouthwestern.edu

Locations
United States, Texas
Children's Medical Center Dallas Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Joshua Koch, MD    214-456-0441    josh.koch@childrens.com   
Principal Investigator: Joshua Koch, MD         
Sub-Investigator: Steven Kernie, MD         
Sub-Investigator: Joseph Forbess, MD         
Sub-Investigator: Craig M Morriss, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
The University of Texas at Arlington
Investigators
Principal Investigator: Joshua Koch, MD UT Southwestern Medical Center at Dallas
  More Information

Additional Information:
No publications provided

Responsible Party: Joshua D. Koch, MD, UT Southwestern Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT01082536     History of Changes
Other Study ID Numbers: CCRAC 120, Perot Grant
Study First Received: March 5, 2010
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Pediatrics
Congenital heart disease
NIRS
Brain oxygenation

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

ClinicalTrials.gov processed this record on August 01, 2014