Preventing Brain Injury in Infants With Congenital Heart Disease

Completed · Phase 1

Conditions studied: Cyanotic Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT01426542

Run by

University of California, Davis

People needed

24

Starts

2011-03-01

Expected to finish

2017-07-28

Last updated by the study team

2019-02-08

Who can join

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

You may qualify if…

• Age less than 2 months
• Cyanotic congenital heart disease requiring surgery

You may not qualify if…

• Genetic syndromes with high risk of neurodevelopmental delay
• Gestational age less than 35 weeks at birth
• Multiple organ failure or multiple organ anomalies

Where it is running

• UC Davis Children's Hospital — Sacramento, California, United States

Full record on ClinicalTrials.gov

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