Objectives of NEMO

 Primary objectives

• 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).

Secondary objectives

• 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.