Objectives of NEMO

Primary objectives

• 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 objective

• To assess pharmacokinetics and pharmacodynamics of bumetanide in neonatal seizure treatment.
• To assess whether successful treatment of neonatal seizures will improve long-term neurodevelopmental outcome in babies with HIE at the age of 24 months.

To further evaluate the mechanisms of action for bumetanide in the immature brain.