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SEVENTH FRAMEWORK PROGRAMME


NEMO summary

The project NEMO addresses the FP7 Health call 'Adapting off-patent medicines to the specific needs of paediatric populations' by investigating the safety and efficacy of bumetanide for the treatment of seizures in babies. Bumetanide is included in the European Medicines Agency (EMEA) revised priority list for studies into off-patent paediatric medicinal products.

Neonatal hypoxic ischaemic encephalopathy (HIE) occurs in 2-3/1000 births and is a major cause of both acute mortality and long-term neurodisability. Electroencephalogram (EEG) studies have shown that many babies with HIE have a considerable seizure burden which is not reduced by current antiepileptic drugs (AED). Better treatments for neonatal seizures, particularly in asphyxiated babies, have been identified as a high priority for research by several international expert groups with the ultimate aim to improve long-term outcome.

NEMO

The aim of NEMO is to develop an effective antiepileptic drug regimen suitable for treatment of neonates with birth asphyxia using innovative strategies targeted specifically to the needs and peculiarities of babies. The focus on this high risk group is justified because of the poor neurodevelopmental outcome for babies with seizures which are resistant to current AEDs. Intensive EEG monitoring will enable us to accurately identify seizures and monitor treatment effect. A European-wide multicentre approach would for the first time allow the performance of a RCT with enough statistical power in this age-group.

By consolidating efforts from basic science, pharmacology and clinical centres, we propose to:

  • Preclinical animal models.
  • A dose-finding explorative study to evaluate the optimal dose of bumetanide to treat neonatal seizures.
  • Establishing a European-wide, multicentre, randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of phenobarbitone and bumetanide for newborns with seizures
  • Monitoring long-term outcome in all children studied.
  • Performing pharmacokinetic/ pharmcodynamic studies of phenobarbitone and bumetanide.

Developing a bumetanide formulation suitable for newborns in order to apply for a Paediatric Use Marketing Authorization (PUMA).

Summary of NEMO