EUCTR2010-020797-41-FI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 seizures using Medication Off-patent. - NEMO1: NEonatal Seizure treatment with Medication Off-patent (v1.0)
Only for Children Pharmaceuticals0 个研究点目标入组 49 人开始时间: 2010年9月22日最近更新:
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:
- •oAPGAR score < 5 at 5 mins.
- •oUmbilical cord or first arterial blood sample pH < 7.1 or base deficit >16 mmol/L.
- •oPostnatal 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.
- •Electrographic seizures, more than cumulative 3 minutes over a period of 2 hours or =2 seizures with durations of 30 seconds each within a 2-hour window.
- •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 within the last 24 hours.
- •Total serum bilirubin > 15 mg/dl (255 micromol/l) at inclusion.
- •On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / pentobarbitone 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.eonatal seizure in Hypoxic Ischaemic EncephalopathyMedDRA version: 14.1Level: LLTClassification code 10061197Term: Neonatal seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-020797-41-SEOnly for Children Pharmaceuticals49
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EMO is an EU FP7 funded project that will be the largest multicentered European study of neonatal seizures and their treatment. The aim of the project is to develop a safe and effective antiepileptic drug (AED) regimen for newborn babies with seizures. Seizures are the most common neurological emergency in the neonatal period and require prompt diagnosis and treatment. The project will evaluate the safety and efficacy of bumetanide in combination with phenobarbitone for seizure controlEUCTR2010-020797-41-IEOnly for Children Pharmaceuticals49
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EMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.eonatal seizure in Hypoxic Ischaemic Encephalopathy.MedDRA version: 14.0Level: LLTClassification code 10061197Term: Neonatal seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-020797-41-NLOnly For Children Pharmaceuticals49
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EMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.EUCTR2010-020797-41-FROnly For Children Pharmaceuticals49