About this trial
Aim of the study To evaluate and compare phenobarbital's and levetiracetam's safety and efficacy for treating seizures in neonates with moderate to severe HIE
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Neonates diagnosed with moderate or severe HIE.
Presence of clinical seizures (focal / generalized tonic /colonic, myoclonic, subtle and spasms) and/or documented amplitude electroencephalogram (aEEG) abnormality within the first 72 hours.
Disqualifiers
Exclusive metabolic causes.
Serum creatinine greater than 1.6 mg/dl.
Known pyridoxine-dependent seizures.
Prior treatment with anti-epileptic drugs.
Trial design
Parallel
Treatments tested in this trial
Phenobarbital
DrugPhenobarbital is strongly recommended by the World Health Organization as the first-line treatment of neonatal seizures and is the standard of care at most institutions
Levetiracetam
Druglevetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of findings anti-seizure Medication safety and efficacy
A complete 24-hour seizure-free period is measured and assessed by clinical symptoms and/or an independent aEEG assessment of seizure-free within 20 to 40 minutes of initiating drug therapy, without the need for second-line antiepileptic therapy.
Secondary outcomes
Comparison of the effectiveness of anti-seizure medications for 48 continuous hours after the start of treatment.
1. Sustained seizure cessation (48 h): Absence of clinical or electrographic seizures for ≥48 consecutive hours after antiseizure therapy. Unit: Yes/No 2. Need for inotropes/vasopressors: Requirement for vasoactive agents (e.g., dopamine) for hypotension within 48 hours. Unit: Yes/No 3. Respiratory support requirement: Need for supplemental oxygen or ventilatory support (CPAP/NIV/mechanical ventilation). Unit: Yes/No 4. Feeding intolerance: Vomiting, abdominal distension, or interruption of enteral feeding. Unit: Yes/No 5. Hematologic abnormalities: Anemia (Hb \<13 g/dL), thrombocytopenia (platelets \<150×10⁹/L), or leukopenia (WBC \<5×10⁹/L). Unit: ×10³/µL 6. Electrolyte disturbances: Abnormal Na, K, Ca, or glucose levels per neonatal reference ranges. Unit: mmol/L 7. Acute liver injury: AST or ALT \>2× age-adjusted upper limit. Unit: IU/L 8. Hyperammonemia: Plasma ammonia \>100 µmol/L. Unit: µmol/L 9. Abnormal blood gas: Metabolic or respiratory acidosis: pH \<7.25 and/or BE ≤ -10 mmol/L.
Sponsors and contacts
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