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Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

Information source: University of California, Davis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypoxic Ischemic Encephalopathy

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of California, Davis

Official(s) and/or principal investigator(s):
Ian J Griffin, MD, Principal Investigator, Affiliation: UC Davis

Overall contact:
Ian J Griffin, MD, Phone: 916-703-5015, Email: ijgriffin@ucdavis.edu


We wish to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.

Clinical Details


Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Seizures

Secondary outcome:

HIE score

Normalization of aEEG

S100-beta levels

MRI score

Developmental Outcome

Detailed description: 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 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 4w post-natal age (which ever is earlier) will be significantly reduced in the topiramate group compared to the control group


Minimum age: N/A. Maximum age: 6 Hours. Gender(s): Both.


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

Locations and Contacts

Ian J Griffin, MD, Phone: 916-703-5015, Email: ijgriffin@ucdavis.edu

UC Davis Medical Center, Sacramento, California 95822, United States; Recruiting
Ian J Griffin, MD, Phone: 916-703-5015, Email: ijgriffin@ucdavis.edu
Kristen Hoffmann, MD
Ian J Griffin, MD, Principal Investigator
Additional Information

Starting date: February 2013
Last updated: March 19, 2015

Page last updated: August 23, 2015

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