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
Summary
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
Official title: TOPIRAMATE AS AN ADJUVANT TO THERAPEUTIC HYPOTHERMIA FOR INFANTS WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY
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 scoreNormalization 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
Eligibility
Minimum age: N/A.
Maximum age: 6 Hours.
Gender(s): Both.
Criteria:
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
|