EUCTR2010-020797-41-NL进行中（未招募）不适用
EMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
Only For Children Pharmaceuticals0 个研究点目标入组 49 人开始时间: 2011年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female term baby with gestational age of 37-43 weeks and postnatal age < 48 hours.
- •- One or more of the following :
- •* APGAR score < 5 at 5 mins.
- •* Umbilical cord or first arterial blood sample pH < 7.1 or base deficit > 16 mmol/L.
- •* Postnatal resuscitation still required 10 minutes after birth.
- •- Clinical evolving encephalopathy.
- •- Received one dose of standard anticonvulsive therapy (phenobarbitone, 20mg/kg) for clinical or electrographic seizures.
- •- EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of > 30 sec duration over a 2 hr period within first 48 hr of life.
- •- Written informed consent of parent or guardian.
- •- EEG monitoring has commenced within the first 48 hours of birth.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenital malformation.
- •- Congenital (in utero) infection (TORCH).
- •- Babies who have received diuretics such as furosemide or bumetanide in routine clinical management.
- •- Total serum bilirubin > 15mg/dL (255 micromol/L) at inclusion.
- •- On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / phenobarbitone for intubation.
- •- Anuria / renal failure defined as serum creatinine > 200 micromol/L.
- •- Severe electrolyte depletion (Na < 120 mmol/L, K < 3.0 mmol/L)
研究者
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EMO1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizures using Medication Off-patent. - NEMO1: NEonatal Seizure treatment with Medication Off-patent (v1.0)EUCTR2010-020797-41-FIOnly for Children Pharmaceuticals49