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NOT YET RECRUITING
NCT07897032
NA

Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia

Sponsor: Alexandria University

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

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