Biomarkers for Detection of Brain Ischemia

NCT00490295 | Completed

• 1 other identifier: IRB00002572
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important. Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical management aimed at increasing oxygen delivery to the brain. Currently there are no FDA approved blood tests to assess brain ischemia in infants undergoing cardiac surgery. Specific Aim 1: We will prospectively study 10 neonates (\< 30 days of age) undergoing cardiac surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation to determine the specificity and sensitivity of a blood test for brain injury. This aim will be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once each day following cardiac surgery as long as the patient remains in the intensive care unit (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B and NSE values will then be correlated with brain magnetic resonance imaging studies before cardiac surgery and at following cardiac surgery. Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the blood of neonates with congenital heart disease who have documented brain injury on brain magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and NSE may correlate to clinical outcome (time to extubation, hospital discharge, neurodevelopmental outcome at 6 months of age). Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac surgery to determine a correlation between neurodevelopment and concentration of S-100B and NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental testing will be done at 6 months following cardiac surgery. Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic resonance imaging documented in specific aim 1 to have a significant decline in neurodevelopment at 6 months after cardiac surgery. Long-term: The long-term goal of this research is to diagnose brain ischemia in infants using a biomarker blood test.

Conditions

Congenital Disorders

Keywords

biomarkers; brain ischemia; neonates; cardiac surgery; congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Diagnose brain ischemia in infants using a biomarker blood test.

  6 months

Study Arms (1)

newborn cardiac surgical study group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Ten consecutive full-term (\>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study

You may qualify if:

• Ten consecutive full-term (\>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study.
• No patient will be excluded because of race or ethnicity.
• Parental or legal guardian consent will be obtained for all patients prior to enrollment.

You may not qualify if:

• Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes involving multiple organs will be excluded from participation.
• Newborns with genetic syndromes associated with developmental delay will also be excluded.
• Newborns with birth asphyxia, 5 minute Apgar score \< 5, will be excluded. Patients with multiple organ failure, syndromes, and birth asphyxia have other causes for neurodevelopmental abnormalities.
• Those patients unable to return for postop follow-up and neurodevelopmental testing will be excluded from participation.
• Those patients with parents/guardians who are unable to read or speak English will be excluded from participation.

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Ischemia; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities

Study Officials

• Janet M Simsic, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 20, 2007
• First Posted: June 22, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)