Irish academic to lead study into seizures in newborns

AN Irish academic who was instrumental in developing methods for more accurate detection of seizures in newborns is to co-lead a major international project to develop new drug treatments for these babies.

Dr Geraldine Boylan, a senior academic at the Department of Paediatrics and Child Health in University College Cork, will jointly lead the €7.5 million project which will involve a European-wide multi-centre clinical trial to evaluate the efficacy and safety of bumetanide in the treatment of seizures in newborns.

Bumetanide has been widely used for decades as a diuretic (to promote the formation of urine by the kidney) in adults and children. Recent research suggests that it may also be effective in the treatment of seizures in the newborn.

The project will evaluate the safety and efficacy of bumetanide for seizure control in newborns.

“This will be the first time that experts from different European countries will collaborate to overcome the ethical and logistical challenges involved in anticonvulsant drug development for babies. We will carefully track the progress and neurological development of these babies which is equally important,” Dr Boylan said.

To date, clinical trials have largely targeted adults rather than children and fewer still focus on newborn babies. Most drugs used to treat seizures in babies are ‘unlicensed’ or ‘off-label’ as their efficacy and safety has not been established in this age group. Over the last 15 years only one new seizure drug has been approved for children less than two years of age and none have been approved for babies.

The research which Dr Boylan will head up is described as “a major boost for paediatric drug development in Europe” because seizures are more common in the neonatal period than any other time throughout life.

The incidence of seizures in babies born at full term (40 weeks) is 1.5-3.0 per 1,000 births: however the incidence is even higher in the more vulnerable group of premature babies, ranging from 50-150 per 1,000 live births.

According to Dr Boylan, “we face an ethical predicament with regard to drug therapy in children and in particular in babies: on the one hand they need protection from the potential risks of unnecessary research, but on the other hand they may be harmed when given inadequately studied medicines. In addition, more effective modern medicines are currently withheld because they have not been studied in this patient group.”