Preventing Brain Injury in Infants With Congenital Heart Disease

• Status: Completed
• Trial end date: 2017-07-28
• Target enrollment: 0
• Participant gender: All

Summary

Newborn babies with congenital heart disease often require surgery in the first month of life. The risks of brain damage from congenital heart disease and from the various corrective surgeries are high because of poor levels of oxygen reaching the brain. Topiramate is an anti-convulsant medication that protects brain cells from damage due to low amounts of oxygen in animal studies. The investigators hypothesize that giving topiramate to babies with congenital heart disease before and after surgery will decrease the amount of brain damage caused by the heart disease and/or the surgery to correct the heart disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Age less than 2 months

• Cyanotic congenital heart disease requiring surgery

Exclusion Criteria:

• Genetic syndromes with high risk of neurodevelopmental delay

• Gestational age less than 35 weeks at birth

• Multiple organ failure or multiple organ anomalies