Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kristin R Hoffman; University of California, Davis
• Treatments: Topiramate

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