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 range6 Hours

SexALL

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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

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