EMO-1:An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent. - NEMO1

Only for Children Pharmaceuticals0 个研究点目标入组 49 人开始时间: 2010年9月10日最近更新: 2013年11月11日

试验速览

暂无简介。

•1. Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours
•2. 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
•3. Clinical evolving encephalopathy
•4. Received one dose of standard anticonvulsive therapy (phenobarbitone, 20mg/kg) for clinical or electrographic seizures.
•5. 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 the first 48 hr of life and after administration of one standard (20mg/kg) dose of phenobarbitone
•6. Written informed consent of parent or guardian.
•7. 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: 49
•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

•1. Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenial malformation
•2. Congenital (in utero) infection (TORCH) if known.
•3. Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours
•4. On any other anticonvulsive medication other than phenobarbitone or or bolus of midazolam / pentobarbitone for intubation.
•6. Severe electrolyte depletion (Na <120 mmol/L, K <3.0 mmol/L)

发起方

Only for Children Pharmaceuticals