Preventing Brain Injury in Infants With Congenital Heart Disease
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|