Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease (CHD Brain)
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|ClinicalTrials.gov Identifier: NCT00932633|
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : February 10, 2016
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 these are full-term infants, the injury seen closely resembles the same form of brain injury that can be seen in premature babies. Much like premature newborns, infants with CHD also have long-term neurodevelopmental problems (in over 50%).
The investigators do not know why infants with CHD get this specific form of brain injury. One risk factor is felt to be the inflammation that occurs in response to heart-lung bypass (cardiopulmonary bypass, or CPB), a necessary feature of open-heart surgery. Newborns have a stronger inflammatory reaction to CPB than older children or adults. The investigators do know from animal experiments and other human data that inflammation can be harmful to the developing brain.
The investigators hypothesize that children with CHD requiring surgery as a newborn have brain injury due to toxicity from the inflammatory response. The investigators will test this by enrolling newborns undergoing heart surgery to measure markers of inflammation, measure brain injury by MRI, and then test their developmental outcome at 1 and 2 years of age.
An association between inflammation and injury might impact what medicines are chosen to protect the brain in future studies, even in other populations such as preterm infants.
|Condition or disease|
|Neonatal Congenital Heart Disease|
|Study Type :||Observational|
|Actual Enrollment :||92 participants|
|Official Title:||Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
- The primary outcome will be a measure of the association of pro-inflammatory cytokines with WMI score [ Time Frame: 5 years ]
- Association between inflammatory response and neurodevelopmental testing [ Time Frame: 5 years ]
- Association of neuroimaging abnormalities with neurodevelopmental testing [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
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): NCT00932633
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||William T Mahle, MD||Emory University|