Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy
Verified date | May 2024 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 34 |
Est. completion date | January 27, 2022 |
Est. primary completion date | January 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Medical Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Kristin R Hoffman |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients With Seizures | 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. | At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) |
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