Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01765218|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2013
Last Update Posted : March 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hypoxic Ischemic Encephalopathy||Drug: Topiramate Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy|
|Actual Study Start Date :||February 2013|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2023|
Placebo Comparator: Placebo
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
A placebo identical in appearance to the active agent (topiramate)
Active Comparator: Topiramate
In addition to whole body cooling, infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
Infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
- Seizures [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]Clinical or electrical seizures occuring before hospital discharge or before 4w post-natal age (which ever is earlier) will be compared between the topiramate and control groups.
- HIE score [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]Differences in daily HIE score between the two groups will be compared from birth to day-5, and from birth to the time of discharge from hospital
- Normalization of aEEG [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]The time for normalization of aEEG voltages will be compared in the two groups.
- S100-beta levels [ Time Frame: Day of life 1, 3 and 7 ]Serum and urine S100beta levels (a marker of neuronal injury) will be compared in the two groups at three time points (on day of life 1, 3, and 7)
- MRI score [ Time Frame: On day 5-7 of life ]The MRI score on day 5 to 7 of life will be compared in the two groups.
- Developmental Outcome [ Time Frame: At 9, 18 and 27 months ]Bayley scales of infant development III will be compared in the two groups at 9, 18 and 27m of age
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): NCT01765218
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95822|
|Principal Investigator:||Kristin R Hoffman, MD||UC Davis|