Preventing Brain Injury in Infants With Congenital Heart Disease
|ClinicalTrials.gov Identifier: NCT01426542|
Recruitment Status : Active, not recruiting
First Posted : August 31, 2011
Last Update Posted : June 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cyanotic Congenital Heart Disease||Drug: Topiramate Other: No medication, but routine heart surgery||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Topiramate Prophylaxis in Infants Undergoing Surgery for Congenital Heart Disease|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Topiramate 5 mg/kg by mouth (or by feeding tube) once a day for one week before and one week after heart surgery.
Active Comparator: Control
These infants will undergo surgery, but will not receive topiramate
Other: No medication, but routine heart surgery
No medication, but routine heart surgery
- Change from baseline in Plasma S100B [ Time Frame: 1 week before surgery, 1 day and 1 week after surgery ]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.
- Mullen Scales of Early Learning [ Time Frame: 18 months of age ]This broad assessment of neurodevelopment includes five scales: Gross Motor, Visual Reception, Fine Motor, Expressive Language, and Receptive Language, with further testing if needed to explore deficits.
- Changes from baseline in urine metabolomics [ Time Frame: 1 week before surgery, 1 day and 1 week after surgery ]Urine specimens obtained at enrollment and at the two time points after surgery will be assessed for a broad range of metabolites (complex molecules). Changes from baseline will be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426542
|United States, California|
|UC Davis Children's Hospital|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mark A Underwood, MD||University of California, Davis|