Levetiracetam Treatment of Neonatal Seizures

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Guangzhou Women and Children's Medical Center; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region; Maternal and Child Health Hospital of Hubei Province; Second Affiliated Hospital of Wenzhou Medical University; The Maternal & Children Health Hospital of Dehong, Yunnan of China; Xiamen Children's Hospital, Fujian of China
• Treatments: Etiracetam; Levetiracetam; Phenobarbital; Piracetam

Criteria

Inclusion Criteria:

Neonatal seizure occurred and was proved by EEG according to abnormal discharge of brain. one or more of the following :

1. Male or female term baby with gestational >37 weeks and postnatal age < or= 28 days

2. Birthweight >2500g

3. Written informed consent of parent or guardian

Exclusion Criteria:

1. Babies who have been close to death

2. Seizure occurred by metabolic factors (hypoglycemia, hypocalcemia, electrolyte disorder)

3. Babies who have received phenobarbitone or any other anticonvulsive medication before hospitalization

4. Abnormal renal function