BRC funded researchers have demonstrated the lack of efficacy of drugs currently in use for neo-natal seizures.
In The Lancet Neurology, Dr Ronit Pressler and members of the Treatment of NEonatal seizures with Medication Off-patent (NEMO) consortium reported the results of a trial to assess the safety and efficacy of Bumetanide, a diuretic with presumed anti-convulsant effects, in newborns with hypoxic ischaemic encephalopathy and seizures not responding to phenobarbital, a barbiturate and first line treatment for neonatal seizures.
Since 2008 Bumetanide has been discussed as a new and promising drug specifically for babies, having been shown to specifically target receptors in seizures in the immature brain.
First author Dr Pressler said: “Phenobarbital is still used with babies, although there are now better drugs with less side effects. It is extremely challenging and ethically and logistically difficult to do trials on newborn babies, hence there are no studies to support the use of other drugs”.
Dr Pressler and her team were awarded an FP7 grant from the European Commission to study Bumetanide. Some 14 newborns were enrolled, however the trial was terminated early because of a concern for possible increased risk of hearing loss and failure to achieve the supposed outcome for seizure control.
Dr Pressler said: “After the second case of hearing loss in one of the babies we temporarily stopped the trial and had an independent safety evaluation which concluded that it was still safe to continue. On re-initiating the trial, a third baby developed hearing loss, at which point we stopped the trial.”
The newborns that were on the trial have several setbacks affecting hearing. Dr Pressler said: “Babies included into the study are immature, they had a hypoxic event which on its own can cause hearing loss and, on top of Bumetanide, they had aminoglycosides – an antibiotic that can be toxic to the ear”.
The researchers have demonstrated that Bumetanide isn’t safe, nor is there evidence that it reduces seizure burden, and at this moment there is no evidence for efficacy.
To read Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO): an open-label, dose finding, and feasibility phase 1/2 trial click here.
