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)
- Conditions
- eonatal seizure in Hypoxic Ischaemic Encephalopathy.MedDRA version: 13.0Level: LLTClassification code 10061197Term: Neonatal seizure in Hypoxic Ischaemic Encephalopathy
- Registration Number
- EUCTR2010-020797-41-FI
- Lead Sponsor
- Only for Children Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 49
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method