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Levetiracetam Treatment of Neonatal Seizures

NCT02550028 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-12-29

No results posted yet for this study

Summary

Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory. A multi-centre Chinese clinical trials with the aim to using oral Levetiracetam to develop new treatment strategies for the treatment of neonatal seizures. The purpose of this study is to determine the correct oral dosing, safety and efficacy for oral Levetiracetam as first line treatment in term new born babies with seizures.

Conditions

  • Neonatal Seizures

Interventions

DRUG

Oral levetiracetam

Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.

DRUG

Intravenous phenobarbital

Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.

Sponsors & Collaborators

  • Xiamen Children's Hospital, Fujian of China

    collaborator OTHER

  • Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region

    collaborator OTHER

  • Guangzhou Women and Children's Medical Center

    collaborator OTHER

  • Second Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Maternal and Child Health Hospital of Hubei Province

    collaborator OTHER

  • The Maternal & Children Health Hospital of Dehong, Yunnan of China

    collaborator OTHER

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Wenhao Zhou, Doctor · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2017-01-01
Completion
2017-01-01

Countries

  • China

Study Locations

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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 NCT02550028 on ClinicalTrials.gov