Hypoxic Ischemic Encephalopathy of NewbornNCT07897032
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
A study testing Levetiracetam and Therapeutic hypothermia (whole body cooling) in people with Hypoxic Ischemic Encephalopathy of Newborn and Neuro-protection, run by Alexandria University at 1 site in Egypt.
Trial summary
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE. Read more about this study
- Who is it for?
- Ages 60 minutes to 6 hours
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
- What is being tested?
- Levetiracetam and Therapeutic hypothermia (whole body cooling)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants will be assessed sequentially by criteria A and B listed below:
- Criteria A:
- Infants ≥ 36 completed weeks gestation admitted to the NICU with at least one of the following:
- Apgar score of ≤ 5 at 5 and/or 10 minutes after birth.
- Signs of fetal distress before delivery (including bradycardia. <100/bpm or tachycardia >160/bpm or meconium-stained amniotic fluid).
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth.
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- Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH < 7.1).
- Base Deficit ≥ 16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth.
- 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:
- Hypotonia.
- Abnormal reflexes including oculomotor or pupillary abnormalities.
- Absent or weak suck.
- Clinical seizures.
Who cannot join
- Obvious major congenital abnormalities.
- Evidence of head trauma causing major intracranial hemorrhage.
- Severe respiratory distress (difficulty maintaining a transcutaneous oxygen saturation [StO2] >95% or a PaO2 >50 mmHg in spite of a fractional concentration of inspired oxygen equal to 1 during mechanical ventilation).
- Severe hypotension with mean blood pressure <30mmHg despite full support (repeated administration of volume expander and maximum inotrope support).
- Severe growth restriction, with birth weight less than 1800 grams.
- Thrombocytopenia <30 000/mm.
- Infants expected to be > 6 hours of age at the time of randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Marwa Mohamed Farag
Alexandria, 0325
Marwa M Farag, 01288681788, d.marwa.farag@gmail.com
Marwa Saeed, PhD
About this study
Official title: Efficacy of Levetiracetam as Adjuvant Therapy to Hypothermia for Management of Neonatal Asphyxia
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
Read the detailed description
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.
- Being tested
- Levetiracetam, Therapeutic hypothermia (whole body cooling)
- Keywords
- neonates, Levetiracetam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Levetiracetam; Other: Therapeutic hypothermia (whole body cooling) |
| Group II (intensive care with cooling): | Active comparator | Received cooling therapy as a sole therapy Receives: Other: Therapeutic hypothermia (whole body cooling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopmental outcome
- Cognitive (CG): 81 items. Scaled score (1-19). Higher = better.
- Language (LANG): 79 items (Receptive 42, Expressive 37). Scaled score (1-19). Higher = better.
- Motor (MOT): 104 items (Fine 46, Gross 58). Scaled score (1-19). Higher = better.
- Social-Emotional (SOEM): 35 items. Scaled score (1-19). Higher = better.
- Adaptive Behavior (ADBE): 120 items (Receptive 23, Expressive 28, Personal 30, Interpersonal 20, Play 19). Standard score (40-160). Higher = better.
Measured: at age of 6 month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic Encephalopathy of NewbornStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897032
- Sponsor's protocol ID
- 0108897
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Levetiracetam as Adjuvant Therapy to Hypothermia for Management of Neonatal Asphyxia
- ClinicalTrials.gov ID
- NCT07897032
- Acronym / sponsor ID
- 0108897
- Keywords
- neonates, Levetiracetam
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical evaluation of the possible neuroprotective effect of early prophylactic high dose of Levetiracetam as adjunctive therapy to WBC in neonates with HIE.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (intensive care with cooling and prophylactic LVT): | Active comparator | Drug: Levetiracetam, Other: Therapeutic hypothermia (whole body cooling)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. |
| Group II (intensive care with cooling): | Active comparator | Other: Therapeutic hypothermia (whole body cooling)Received cooling therapy as a sole therapy |
Who may qualify
- Ages
- 60 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Infants will be assessed sequentially by criteria A and B listed below:
- Infants ≥ 36 completed weeks gestation admitted to the NICU with at least one of the following:
- Apgar score of ≤ 5 at 5 and/or 10 minutes after birth.
- Signs of fetal distress before delivery (including bradycardia. <100/bpm or tachycardia >160/bpm or meconium-stained amniotic fluid).
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth.
Key exclusion criteria (7 listed)
- Obvious major congenital abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levetiracetamprophylactic 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 | Group I (intensive care with cooling and prophylactic LVT): |
| 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. | Other | Group I (intensive care with cooling and prophylactic LVT):, Group II (intensive care with cooling): |
Primary outcome
neurodevelopmental outcome
Time frame: at age of 6 month after birth
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levetiracetam and Therapeutic hypothermia (whole body cooling) in people with Hypoxic Ischemic Encephalopathy of Newborn and Neuro-protection, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Farag, PhD (01288681788, d.marwa.farag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurodevelopmental outcome (time frame: at age of 6 month after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.