Clinical Trial: Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional
Official Title: TOPIRAMATE AS AN ADJUVANT TO THERAPEUTIC HYPOTHERMIA FOR INFANTS WITH HYPOXIC ISCHEMIC ENCEPHALOPATHY
Brief Summary: We wish to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.
Detailed Summary: 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 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 4w post-natal age (which ever is earlier) will be significantly reduced in the topiramate group compared to the control group
Sponsor: University of California, Davis
Current Primary Outcome: Seizures [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]
Original Primary Outcome: Seizures [ Time Frame: At 4w post-natal age or the time of hospital discharge (whichever is earlier) ]
Current Secondary Outcome:
- HIE score [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]Differences in daily HIE score between the two groups will be compared from birth to day-5, and from birth to the time of discharge from hospital
- Normalization of aEEG [ Time Frame: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) ]The time for normalization of aEEG voltages will be compared in the two groups.
- S100-beta levels [ Time Frame: Day of life 1, 3 and 7 ]Serum and urine S100beta levels (a marker of neuronal injury) will be compared in the two groups at three time points (on day of life 1, 3, and 7)
- MRI score [ Time Frame: On day 5-7 of life ]The MRI score on day 5 to 7 of life will be compared in the two groups.
- Developmental Outcome [ Time Frame: At 9, 18 and 27 months ]Bayley scales of infant development III will be compared in the two groups at 9, 18 and 27m of age
Original Secondary Outcome:
- HIE score [ Time Frame: At 4w post-natal age or the time of hospital discharge (whichever is earlier) ]Differences in daily HIE score between the two groups will be compared from birth to day-5, and from birth to the time of discharge from hospital
- Normalization of aEEG [ Time Frame: At 4w post-natal age or the time of hospital discharge (whichever is earlier) ]The time for normalization of aEEG voltages will be compared in the two groups.
- S100-beta levels [ Time Frame: Day of life 1, 3 and 7 ]Serum and urine S100beta levels (a marker of neuronal injury) will be compared in the two groups at three time points (on day of life 1, 3, and 7)
- MRI score [ Time Frame: On day 5-7 of life ]The MRI score on day 5 to 7 of life will be compared in the two groups.
- Developmental Outcome [ Time Frame: At 9m, 18m and 27m of age ]Bayley scales of infant development III will be compared in the two groups at 9, 18 and 27m of age
Information By: University of California, Davis
Dates:
Date Received: January 7, 2013
Date Started: February 2013
Date Completion: February 2018
Last Updated: February 13, 2017
Last Verified: November 2016
