NCT00932633|CompletedDMC
Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease
CHD Brain
Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery
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CHD Brain
Role of Inflammatory Response in Brain Injury Following Neonatal Cardiac Surgery
Sponsor study identifier
Secondary identifiers
OTHER · Other
observational
92
1 country
1
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2009
Actual (reported)July 3, 2009
Actual (reported)August 2009
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)January 2016
Actual (reported)The primary outcome will be a measure of the association of pro-inflammatory cytokines with WMI score
5 years
Association between inflammatory response and neurodevelopmental testing
5 years
Association of neuroimaging abnormalities with neurodevelopmental testing
5 years
newborns with congenital heart disease requiring surgery during the first 30 days of life
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
dried blood spot sample
William T Mahle, MD
Emory University
92 participants (actual enrollment reported by the registry).
First Submitted
July 1, 2009
First Posted
July 3, 2009
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
February 10, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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