Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
Hypoxic Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic ischemic encephalopathy, HIE, Perinatal depression, Whole body cooling, Therapeutic hypothermia
Eligibility Criteria
Inclusion Criteria:
In order to be eligible for cooling the baby must meet all three of the following sets of criteria
- Be near term (typically ≥34wks gestation) and be aged < 6h old
- Have signs of early perinatal depression (EITHER 10 minute Apgar score < 5, OR pH < 7.00 within 60mins of age, OR Base Excess < -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression)
- Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment
Exclusion Criteria:
- Known congenital myopathy
- Known congenital neuropathy
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Topiramate
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
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.