Status:
COMPLETED
Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Neonatal Congenital Heart Disease
Eligibility:
All Genders
Up to 30 years
Brief Summary
Infants with congenital heart disease (CHD) requiring surgery frequently have brain injury seen on magnetic resonance imaging (MRI). This occurs in approximately 40% of these newborns, and even though...
Detailed Description
Term infants with congenital heart disease (CHD) requiring neonatal surgery have an unusual susceptibility to white matter injury (WMI), a neuropathology typically seen in preterm infants. The mechani...
Eligibility Criteria
Inclusion
- Term or near-term (\> 35 week gestation) neonates with CHD presenting for cardiac surgery
- Less than 30 days old
- No patient will be excluded because of race or ethnicity
- Parental or legal guardian consent will be obtained for all patients prior to enrollment
Exclusion
- Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes will be excluded from participation
- Newborns with either genetic syndromes or congenital infections that are associated with developmental delay will also be excluded
- Newborns with perinatal depression as defined by a cord blood gas pH \< 7.0 or a 5 minute Apgar score \< 5, will be excluded
- Patients with multiple organ failure, syndromes, and perinatal depression have other causes for neurodevelopmental abnormalities
- Those patients unable to return for postoperative follow-up and neurodevelopmental testing will also be excluded from participation
- Parent or legal guardian unable or unwilling to consent
- Non-English speaking families
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00932633
Start Date
August 1 2009
End Date
January 1 2016
Last Update
February 10 2016
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322