Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Infectious Disease, Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/2/2018 |
| Start Date: | February 2013 |
| End Date: | May 2020 |
| Contact: | Kristin R Hoffman, MD |
| Email: | krhoffman@ucdavis.edu |
| Phone: | 916-734-3261 |
Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy
The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of
babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
Hypoxic ischemic encephalopathy (HIE) is a devastating and unexpected disease in newborns
that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality
rate of up to 30% and survivors are at significant risk for adverse long-term outcomes,
including seizures, cerebral palsy, and developmental delay. The investigators propose a
randomized controlled study comparing therapeutic hypothermia alone, or therapeutic
hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy
with topiramate will reduce short term severity of HIE including seizures (the primary
outcome), a composite HIE severity score, and reduce the time of normalization of the
amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve
longer term outcomes such as developmental outcome. The primary hypothesis is that seizures
before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be
significantly reduced in the topiramate group compared to the control group
that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality
rate of up to 30% and survivors are at significant risk for adverse long-term outcomes,
including seizures, cerebral palsy, and developmental delay. The investigators propose a
randomized controlled study comparing therapeutic hypothermia alone, or therapeutic
hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy
with topiramate will reduce short term severity of HIE including seizures (the primary
outcome), a composite HIE severity score, and reduce the time of normalization of the
amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve
longer term outcomes such as developmental outcome. The primary hypothesis is that seizures
before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be
significantly reduced in the topiramate group compared to the control group
Inclusion Criteria:
In order to be eligible for cooling the baby must meet all three of the following sets of
criteria
1. Be near term (typically ≥34wks gestation) and be aged < 6h old
2. 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)
3. Have signs of moderate or severe encephalopathy based on either clinical examination
or on amplitude integrated aEEG assessment
Exclusion Criteria:
1. Known congenital myopathy
2. Known congenital neuropathy
We found this trial at
1
site
Sacramento, California 95814
Principal Investigator: Kristin R Hoffman, MD
Phone: 916-734-3261
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