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

Phase 1

• Conditions: eonatal seizure in Hypoxic Ischaemic Encephalopathy.; MedDRA version: 13.0Level: LLTClassification code 10061197Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2010-020797-41-FR
• Lead Sponsor: Only For Children Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• 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 :
* 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.
- 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

Exclusion Criteria

- 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.
- Total serum bilirubin > 15mg/dL (255 micromol/L) at inclusion.
- On any other anticonvulsive medication other than phenobarbitone or bolus of midazolam / phenobarbitone 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