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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Sponsor: Alexandria University
Summary
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
Official title: Efficacy of Levetiracetam as Adjuvant Therapy to Hypothermia for Management of Neonatal Asphyxia
Key Details
Gender
All
Age Range
60 Minutes - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-11-01
Completion Date
2027-02-01
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Levetiracetam
prophylactic LVT using a dose of 60 mg per kilogram followed by eight maintenance doses 15mg /kg every 8 hours will be administered intravenously over a fixed time of 15 min through a central or peripheral line for a 3-day treatment period.
Therapeutic hypothermia (whole body cooling)
Cooling will be commenced as early as possible, within the first 6 hours of birth and with a rectal temperature of 33 °C - 34 °C for 72 hours. Throughout hypothermic treatment and rewarming, rectal temperature will be monitored continuously using a rectal probe placed 3cm from the anus and is recorded hourly. The infant will be naked in an open incubator, in a room at a temperature of 20 to 23°C. In case there is excessive hypothermia (\<33°C), the cooled packs or mattress will be removed. If that is not sufficient the radiant heater will be switched on at minimal power until the axillary temperature rises above 33°C. After 72 hours of WBC, rewarming to a rectal temperature of 37°C will be conducted slowly over at least 7 hours. This can be achieved by adjusting the temperature of the radiant heater so that the patient's rectal temperature increases by no more than 0.5°C per hour.
Locations (1)
Marwa Mohamed Farag
Alexandria, Egypt