An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent (NEMO). - Neonatal seizures using medication off patent (NEMO).

Only For Children Pharmaceuticals0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•* 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 minutes
•- 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, 20 mg/kg) for clinical or electrographic seizures
•* EEG: equal to or more than 3 minutes 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

•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 within the past 24 hours in routine clinical management
•Total serum bilirubin > 15 mg/dl (255 micro mol/ll) at inclusion
•On any other anticonvulsive medication other than phenobarbitone or single doses(s) of midazolam for intubation.
•Anuria/renal failure defined as serum creatinine > 200 micro mol/l.
•Severe electrolyte depletion (Na <120mmol/l, K <3.0mmol/l)

发起方

Only For Children Pharmaceuticals