Analysis of Cerebral Perfusion Using Head Ultrasound and Multisource Detector Near Infrared Spectroscopy (NIRS) Imaging

NCT01082536 | Withdrawn

• 2 other identifiers: CCRAC 120Perot Grant
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Keywords

Pediatrics; Congenital heart disease; NIRS; Brain oxygenation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12 months

Secondary Outcomes (2)

• 2. Evaluate whether changes in resistive indices as determined by cranial ultrasound after cardiopulmonary bypass are associated with major neurologic dysfunction.

  12 months

• 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.

  12 months

Study Arms (6)

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.

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• The University of Texas at Arlington: collaborator

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Related Links

• Children's Medical Center Dallas

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Nancy Rollins, MD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: March 28, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

US (1)