During or just after birth many babies suffer from an inadequate intake of oxygen. Known as birth asphyxia this dangerous condition occurs in approximately 10 per 1,000 live births and is responsible for 23% of the 4 million newborn deaths worldwide each year.
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The lack of oxygen at birth is also an important cause of lifelong disabilities and learning difficulties. Many babies who experience birth asphyxia suffer fits (epileptic seizures) which can go unnoticed and can make the condition worse or cause additional brain damage.
The European Union (EU)-funded NEMO project brought together an international team of renowned experts to develop an effective drug that could treat seizures due to birth asphyxia and improve the long-term prospects of this vulnerable patient group.
Drug treatment for seizures in babies has not significantly changed over the last 50 years. The first choice drug worldwide is still Phenobarbitone, despite evidence that it is only effective in 30-50% of babies and might have side-effects on the brain development.
A key part of the five-year NEMO project is a series of Europe-wide multicentre studies to evaluate promising antiepileptic drugs suitable for use in newborn babies.
“The strength of NEMO project is the team which consists of scientists and clinicians with worldwide reputation, working together on the diagnosis and treatment of seizures in newborn babies,” says project coordinator Dr Ronit Pressler of the Great Ormond Street Hospital for Children, London, United Kingdom.
Integrating the latest scientific and technological advances in the field, the research team has applied various innovative methods to overcome the challenges in conducting clinical trials involving babies.
By monitoring the electrical activity of the brain - using EEG (electroencephalogram) technology - the NEMO team was able to accurately identify seizures and better monitor the progress of the treatment.
“The first clinical trial has finished and a larger trial is being planned to evaluate another promising drug for treating newborn babies suffering from seizures,” explains Dr Pressler.
In the words of Dr Pressler, the team is on target for developing a drug formulation suitable for newborn babies which can then be submitted for a Paediatric Use Marketing Authorisation (PUMA). “The development of new seizure drugs could potentially reduce infant deaths and minimise the lifetime economic and social impact,” concludes Dr Pressler.
10th February 2014 - European Epilepsy Day