Summary

at Sacramento, California
study started
estimated completion
Kristin R Hoffman, MD

Description

Summary

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.

Official Title

Topiramate as an Adjuvant to Therapeutic Hypothermia for Infants With Hypoxic Ischemic Encephalopathy

Details

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

Keywords

Hypoxic Ischemic Encephalopathy HIE Perinatal depression Whole body cooling Therapeutic hypothermia Ischemia Brain Diseases Hypoxia Brain Ischemia Hypoxia-Ischemia, Brain Topiramate Toprimate

Eligibility

You can join if…

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

You CAN'T join if...

  1. Known congenital myopathy
  2. Known congenital neuropathy

Location

  • UC Davis Medical Center accepting new patients
    Sacramento California 95822 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kristin R Hoffman
Links
Sign up for this study
ID
NCT01765218
Phase
Phase 1/2
Study Type
Interventional
Last Updated