Magnetic Resonance Imaging (MRI) to Evaluate Brain Injury in Congenital Heart Disease

Completed

Conditions studied: Neonatal Congenital Heart Disease

In brief

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.

Key facts

Study ID: NCT00932633
Run by: Emory University
People needed: 92
Starts: 2009-08-01
Expected to finish: 2016-01-01
Last updated by the study team: 2016-02-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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 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

Where it is running

Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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