Preventing Brain Injury in Infants With Congenital Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

NCT01765218

Hypoxic Ischemic Encephalopathy

TERMINATED PHASE1/PHASE2

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

NCT00556361

Ventricular Septal Defect

COMPLETED PHASE2

Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population

NCT00207935

Epilepsy Mental Retardation Developmental Disabilities

COMPLETED PHASE4

The Prevalence and Risk Factors of Coagulopathy in Pediatric Epilepsy Surgery Patients

NCT05675254

Epilepsy in Children Coagulation and Hemorrhagic Disorders Epilepsy; Seizure +1 more

COMPLETED

Prevention of Epilepsy by Reducing Neonatal Encephalopathy

NCT04054453

Neonatal Encephalopathy Epilepsy Newborn Morbidity

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Infants with cyanotic congenital heart disease undergoing surgery in the neonatal period have a high rate of brain injury resulting in seizures, stroke, cerebral palsy, and neurodevelopmental delays. Neuroimaging abnormalities are found in 30% to 60% of cases and neurodevelopmental impairments occur in more than half of these children. The mechanisms of brain injury in these children are not fully understood. Experimental animal models have shown that the abundant release of glutamate in the brain during hypoxic-ischemic insult results in brain injury. Blocking glutamate receptors by administration of the anticonvulsant topiramate has been shown to prevent such injury in animal studies. This study is an open pilot trial of peri-operative topiramate administration to infants with cyanotic congenital heart disease to test the feasibility of this approach and generate preliminary data about markers of brain injury (serum S100B levels and urine metabolomics) and neurodevelopment at 18 months of age. If the approach is feasible and the preliminary data are encouraging a larger efficacy trial will be designed. Although topiramate has been used in neonates and infants to treat seizures and in a pilot study in term infants with hypoxic-ischemic encephalopathy, this is the first study of its effects on markers of brain injury and neurologic outcomes in infants with cyanotic congenital heart disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cyanotic Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Topiramate

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

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

Control

These infants will undergo surgery, but will not receive topiramate

Group Type ACTIVE_COMPARATOR

No medication, but routine heart surgery

Intervention Type OTHER

No medication, but routine heart surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topiramate

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

Intervention Type DRUG

No medication, but routine heart surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No