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Preventing Brain Injury in Infants With Congenital Heart Disease

NCT01426542 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-08

No results posted yet for this study

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.

Conditions

  • Cyanotic Congenital Heart Disease

Interventions

DRUG

Topiramate

Topiramate 5 mg/kg by mouth (or by feeding tube) once a day for one week before and one week after heart surgery.

OTHER

No medication, but routine heart surgery

No medication, but routine heart surgery

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mark A Underwood, MD · University of California, Davis

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2017-07-28
Completion
2017-07-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01426542 on ClinicalTrials.gov