NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Bumetanide - Standard Phenobarbital plus either 0.05 mg/kg,0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the the dose escalation design Maximum dose allowed is 0.3mg/kg given up to 4 times at 12 hourly intervals (total of 1.2mg/kg).
Cork University Maternity Hospital
Cork, Ireland
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Karolinska Institutet and University Hospital
Stockholm, Sweden
Optimal dose finding
The optimal dose is defined as achieving effective seizure reduction: * Reduction of electrographic seizure (measuresd by EEG) burden by \>80% during the 3rd and 4th hour after the first bumetanide administration compared to a 2 hour epoch prior to Bumetanide administration. * No need for rescue AED within 48 hours
Time frame: 6 months
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Uppsala University Hospital
Uppsala, Sweden
Leeds General Infirmary
Leeds, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom