EUCTR2010-020797-41-IEActive, not recruitingNot Applicable
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 sites49 target enrollmentStarted: September 10, 2010Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 49
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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