An interventional study of Levetiracetam and Therapeutic hypothermia (whole body cooling) in Hypoxic Ischemic Encephalopathy of Newborn and Neuro-protection, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 60 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
The intervention group will receive 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.
Alexandria University is the lead sponsor of 596 studies on the registry; 134 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Criteria A:
Infants ≥ 36 completed weeks gestation admitted to the NICU with at least one of the following:
All infants who meet criteria A will be further assessed whether they meet the neurological abnormalities included in criteria (B).
Criteria B:
Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) and at least one of the following:
Exclusion Criteria:
Obvious major congenital abnormalities.
with 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.
Drug: Levetiracetam · Other: Therapeutic hypothermia (whole body cooling)
Received cooling therapy as a sole therapy
Other: Therapeutic hypothermia (whole body cooling)
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.
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.
neurodevelopmental outcome
1. Cognitive (CG): 81 items. Scaled score (1-19). Higher = better. 2. Language (LANG): 79 items (Receptive 42, Expressive 37). Scaled score (1-19). Higher = better. 3. Motor (MOT): 104 items (Fine 46, Gross 58). Scaled score (1-19). Higher = better. 4. Social-Emotional (SOEM): 35 items. Scaled score (1-19). Higher = better. 5. Adaptive Behavior (ADBE): 120 items (Receptive 23, Expressive 28, Personal 30, Interpersonal 20, Play 19). Standard score (40-160). Higher = better.
Time frame: at age of 6 month after birth
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Levetiracetam