EUCTR2010-020797-41-SEActive, not recruitingNot Applicable
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)
Only for Children Pharmaceuticals0 sites49 target enrollmentStarted: October 13, 2010Last updated:
Conditions
Drugs
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
- •Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours
- •One or more of the following:
- •o APGAR score < 5 at 5 mins.
- •o Umbilical cord or first arterial blood sample pH < 7.1 or base deficit >16 mmol/L.
- •o Postnatal 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 within the first 48 hours of life and after administration of one standard (20mg/kg) dose of phenobarbitone.
- •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
Exclusion Criteria
- •Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenital malformation
- •Congenital (in utero) infection (TORCH) if known
- •Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours.
- •On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / pentobarbitone for intubation.
- •Severe electrolyte depletion (Na < 120 mmol/L, K <3.0 mmol/L)
Investigators
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