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Hypoxic Ischemic Encephalopathy | Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

Hypoxic Ischemic Encephalopathy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypoxic Ischemic Encephalopathy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:TopiramateInfants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.

Drug:PlaceboA placebo identical in appearance to the active agent (topiramate)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboSubjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)

ToprimateIn addition to whole body cooling, infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.

Study Status

Recruiting

Start Date: February 2013

Completed Date: May 2020

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Seizures

Secondary Outcome: HIE score

Study sponsors, principal investigator, and references

Principal Investigator: Kristin R Hoffman, MD

Lead Sponsor: Kristin R Hoffman

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01765218

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