drugset / Trial / NCT01426542

Preventing Brain Injury in Infants With Congenital Heart Disease

NCT01426542

Phase 1 Completed 24 enrolled University of California, Davis
Non-randomizedSingle-groupOpen-labelPrevention

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.

Timeline

Start
2011-03
Primary completion
2017-07-28
Completion
2017-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 5 mg/kg Oral