TerminatedPhase 1/2

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

Stopped: The study was stopped early due to changes in the UC Davis guidelines on who qualified for therapeutic hypothermia and significant difficulty in recruitment of patients following the COVID19 pandemic.

United States34 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range

6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Be near term (typically ≥34wks gestation) and be aged \< 6h old
. 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)
. Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment

Exclusion criteria

. Known congenital myopathy
. Known congenital neuropathy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients With Seizures

Timeframe: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)

Trial details

NCT IDNCT01765218

SponsorKristin R Hoffman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-27

Results submitted2023-12-19

View on ClinicalTrials.gov More Hypoxic Ischemic Encephalopathy trials