NEMO1: An Open Label Exploratory Dose Finding and Pharmacokinetic Clinical Trial of Bumetanide for the Treatment of Neonatal Seizure Using Medication Off-patent
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 7
- 主要终点
- Optimal dose finding
研究概览
简要总结
NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Clinically 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 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.
排除标准
- •Suspected or confirmed brain malformation, inborn error of metabolism,genetic syndrome, or major congenial 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)
研究组 & 干预措施
Bumetanide
Bumetanide - Standard Phenobarbital plus either 0.05 mg/kg,0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the the dose escalation design Maximum dose allowed is 0.3mg/kg given up to 4 times at 12 hourly intervals (total of 1.2mg/kg).
干预措施: Bumetanide (Drug)
结局指标
主要结局
Optimal dose finding
时间窗: 6 months
The optimal dose is defined as achieving effective seizure reduction: * Reduction of electrographic seizure (measuresd by EEG) burden by \>80% during the 3rd and 4th hour after the first bumetanide administration compared to a 2 hour epoch prior to Bumetanide administration. * No need for rescue AED within 48 hours
次要结局
未报告次要终点