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临床试验/NL-OMON22555
NL-OMON22555尚未招募不适用

Safety of intravenous levetiracetam for in neonates with seizures

same0 个研究点目标入组 10 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. All neonates with electrographical epileptic seizures, diagnosed by EEG,
  • a. with or without clinical signs;
  • b. multiple (>1 in 30’), defined as the evolution of sudden, repetitive evolving stereotyped forms with a definite beginning, middle and end, lasting at least 8 seconds;
  • c. or status epilepticus, defined as continuous seizure activity for at least 30 minutes or recurrent seizure activity for >50% of the entire recording duration.
  • 2. Newborn gestational age > 37 weeks, birth weight > 1500 grams;
  • 3. Refractory to phenobarbitone up to 40 mg/kg or refractory to phenobarbitone up to 40 mg/kg and midazolam up to 0.5 mg/kg (raised from 0.1 mg/kg every 10-15 minutes when effect fails) (depending on moment of referral with history of medication);
  • 4. After correction or treatment of metabolic causes of the as inborn errors, hypoglycaemia or hypocalcaemia or CNS infections;
  • 5. Arterial catheter

排除标准

  • 1. Newborn gestational age < 37 weeks;
  • 2. Birth weight < 1500 grams

研究者

发起方
same

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