Trials Sponsors Conditions Drugs Pricing

Conditions

Hypoxic Ischemic Encephalopathy of Newborn Neuro-protection

Keywords

neonatesLevetiracetam

Outcome Measures

Primary Outcomes (1)

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.
at age of 6 month after birth

Study Arms (2)

Group I (intensive care with cooling and prophylactic LVT):

ACTIVE COMPARATOR

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: LevetiracetamOther: Therapeutic hypothermia (whole body cooling)

Group II (intensive care with cooling):

ACTIVE COMPARATOR

Received cooling therapy as a sole therapy

Other: Therapeutic hypothermia (whole body cooling)

Interventions

LevetiracetamDrug

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.

Group I (intensive care with cooling and prophylactic LVT):

Therapeutic hypothermia (whole body cooling)Other

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.

Eligibility Criteria

Age60 Minutes - 6 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Infants will be assessed sequentially by criteria A and B listed below:
Criteria A:

Sponsors & Collaborators

Alexandria University
Otherlead

Study Sites (1)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

Marwa M FaragCONTACT01288681788 d.marwa.farag@gmail.com

Marwa Saeed, PhDCONTACT

MeSH Terms

Interventions

LevetiracetamHypothermia, Induced

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCryotherapyTherapeutics

Central Study Contacts

Marwa M Farag, PhD

CONTACT

01288681788 d.marwa.farag@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant professor of Pediatrics

Study Record Dates

First Submitted

July 24, 2026

First Posted

October 27, 2026

Study Start

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

February 1, 2027

Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Group I (intensive care with cooling and prophylactic LVT):

Group II (intensive care with cooling):

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Group I (intensive care with cooling and prophylactic LVT):

Group II (intensive care with cooling):

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations