EMO1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal Seizures using Medication Off-patent.

• Conditions: eonatal seizure in Hypoxic Ischaemic Encephalopathy; MedDRA version: 14.1Level: LLTClassification code 10061197Term: Neonatal seizuresSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020797-41-SE
• Lead Sponsor: Only for Children Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-13
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 49

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified