Preventing Brain Injury in Infants With Congenital Heart Disease

NCT01426542 | Completed Phase 1

• 1 other identifier: 216534
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

brain injury; stroke; cerebral palsy; seizures

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Plasma S100B

  Baseline plasma S100B levels will be determined prior to surgery (at enrollment) with repeat levels at the two timepoints after surgery. Main outcome will be change from baseline.

  1 week before surgery, 1 day and 1 week after surgery

Secondary Outcomes (2)

• Mullen Scales of Early Learning

  18 months of age

• Changes from baseline in urine metabolomics

  1 week before surgery, 1 day and 1 week after surgery

Study Arms (2)

Topiramate

EXPERIMENTAL

Drug: Topiramate

Control

ACTIVE COMPARATOR

These infants will undergo surgery, but will not receive topiramate

Other: No medication, but routine heart surgery

Interventions

Topiramate DRUG

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

Topiramate

No medication, but routine heart surgery OTHER

No medication, but routine heart surgery

Control

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Children's Hospital

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Cerebral Palsy; Seizures

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Mark A Underwood, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 31, 2011
• Study Start: March 1, 2011
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

US (1)