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Treatment of Seizures in Neonate With HIE

NCT07284498 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-12-16

No results posted yet for this study

Summary

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

Conditions

  • Neonatal Seizures
  • HIE - Hypoxic - Ischemic Encephalopathy

Interventions

DRUG

Phenobarbital

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

DRUG

Levetiracetam

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Moetaza Soliman, Associate Professor · Faculty of Pharmacy, Mansoura University

  • Nada Abdelfattah, Associate Professor · University Children's Hospital, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284498 on ClinicalTrials.gov