Objectives of NEMO
- To find the optimal dose of bumetanide when given as addition to standard therapy (phenobarbitone) for seizures in full term babies with hypoxic ischemic encephalopathy.
- To assess the efficacy and safety of bumetanide for the treatment of neonatal seizures in babies with hypoxic ischaemic encephalopathy which are not controlled by phenobarbitone.
- To develop and adapt a bumetanide formulation suitable for newborns with seizures and to apply for a Paediatric Use Marketing Authorization (PUMA).
- To assess pharmacokinetics and pharmacodynamics of bumetanide in neonatal seizure treatment.
- To assess whether successful treatment of neonatal seizures will improve long-term neuro-developmental outcome in babies with HIE at the age of 24 months.
- To further evaluate the mechanisms of action for bumetanide in the immature brain.
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