Treatment of Seizures in Neonate With HIE

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-30
SponsorMansoura University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Phenobarbital

    Drug

    Phenobarbital 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

    Drug

    levetiracetam has emerged as an alternative Anti-seizure medication that may offer improved safety and tolerability profiles.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Phenobarbital Arm ( Group A )Active comparator 1 intervention
Group B: Levetiracetam Standard Dose Arm ( Group B )Active comparator 1 intervention
Group C: Levetiracetam High Dose Arm ( Group C )Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24-hour seizure-free period.

Secondary outcomes

1

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.

Time frame
48 hours after initiation of treatment

Other outcomes

Sponsors and contacts

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