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

Phase 2

Completed

• Conditions: epilepsy; 10028920; seizures; 10010335

• Registration Number: NL-OMON36769
• Lead Sponsor: Only For Children Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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 minutes
- 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, 20 mg/kg) for clinical or electrographic seizures
* EEG: equal to or more than 3 minutes cumulative seizures, or 2 or more seizures of > 30 sec duration over 2 hr period within first 48 hr of life
* Written informed consent of parent or guardian
* EEG monitoring has commenced within the first 48 hours of birth

Exclusion Criteria

•Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenial malformation
•Congenital (in utero) infection (TORCH).
•Babies who have received diuretics such as furosemide or bumetanide within the past 24 hours in routine clinical management
•Total serum bilirubin > 15 mg/dl (255 micro mol/ll) at inclusion
•On any other anticonvulsive medication other than phenobarbitone or single doses(s) of midazolam for intubation.
•Anuria/renal failure defined as serum creatinine > 200 micro mol/l.
•Severe electrolyte depletion (Na <120mmol/l, K <3.0mmol/l)

Study & Design

• Study Type: Interventional
• Study Design: Not specified