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Professor Geraldine Boylan

Multicentered European study of neonatal seizures and their treatment

NEMO leaflet cover

Professor Geraldine Boylan, a HRB funded clinical scientist and director of the Neonatal Brain Research Group, UCC is funded under FP7 to co-coordinate a clinical trial of off-patent medication for treating seizures in new born babies.

Geraldine who is an expert in neonatal neurophysiology had initially received funding from the HRB to study a group of 70 high risk babies admitted to the neonatal intensive care unit at Cork University Maternity Hospital over a two-year period. The purpose was to gather EEG and other data such as heart rate, that could be used to devise an automated seizure detection system. Her group then received additional funding from the HRB to follow up these babies clinically to the age of five to see if seizures around the time of birth lead to learning difficulties or other problems later in childhood. Further details about the group's research can be found at http://neonatalbrain.ucc.ie

The FP7 NEMO project which Geraldine co-coordinates is the largest multicentred European study of neonatal seizures and their treatment (http://www.nemo-europe.com). A multicentre study at European level was necessary in order to recruit enough patients for an effective study and FP7 collaborative funding provided the means to do this. Seizures or fits which occur in new born babies shortly after birth (neonatal seizures) are the focus of the NEMO project.

The aim of the study is to investigate the safety and efficacy of bumetanide, for the treatment of seizures in babies. The NEMO study will evaluate bumetanide, a drug targeted at an age dependent mechanism which is thought to be responsible for the high incidence of seizure in the neonatal period. This will be the first time that an antiepileptic drug (AED) specifically aimed at this age-group will be evaluated in a large, adequately powered, randomised trial with EEG monitoring, recognised to be the "gold standard" method for seizure diagnosis in the newborn. Most previous studies have only used clinical assessment of neonatal seizures to guide treatment and this has shown to be inaccurate. Bumetanide cannot be tested as an AED on older children or adults as this mechanism ceases to be effective during the first few months of life. Bumetanide is included in the European Medicines Agency's (EMA) revised priority list for studies into off-patent paediatric medicinal products.

The NEMO consortium which is funded for five years consists of 15 participating institutions and partners based in Europe and the USA, and is worth over €5.8 million.

Geraldine's first experience of European funding came when she initially applied to become an evaluator in FP7 which she says 'is a great way of networking with other researchers and it allows you to become familiar with the evaluation process'. See document on how to become an evaluator.

Shortly after evaluating proposals in Brussels, an opportunity arose for Geraldine with the FP7 health call on 'adapting off-patent medicines to the specific needs of paediatric populations' which Geraldine naturally jumped at the chance to be involved in. She had a colleague at Great Ormond Street Hospital, London, Dr Ronit Pressler with whom she had worked previously. Geraldine and Ronit had carried out research on accurately diagnosing seizures or 'fits' in new-born babies by monitoring electrical brain activity. Together they set about putting a consortium together using their contacts across Europe. In some cases these were contacts they had previously met at conferences and this was now a chance to collaborate with them. Some required a bit of persuasion as many were already committed to other projects. Geraldine and Ronit quickly realised that in order to get a 'dream team' together, they would have to be organised and make it clear from the outset what the workload would entail for each consortium member. Geraldine also found that picking up the phone and talking to people was the best way of getting them on board. This was Geraldine's first time to engage with FP7 as a partner or coordinator.

During preparation of the proposal, Geraldine worked closely with Dr Caitriona Creely (one of two National Contact Points who are based at the HRB), who guided her through the FP7 process. She gave her feedback on the scientific approach for her proposal as well as giving advice on how well the research fitted with the topic. 'Caitriona was invaluable to bounce ideas off as she knows how the Commission works and what would be acceptable. The financing side of things can be tricky to navigate but Caitriona always had advice to hand, and if she didn't know the answer, she put me in touch with someone who did. In addition she always responded to my queries promptly'. When the funding was awarded, Caitriona also assisted the consortium at the negotiation stage with the Commission which can be a difficult task. In fact Caitriona attended the induction meeting in Brussels with the Consortium as well as attending the meeting the Consortium had with the EU project officer.

Geraldine acknowledges the assistance of the HRB NCP as being invaluable. 'If anyone asks my advice now on EU funding my first reaction is to tell them to contact their NCP immediately. We are very luck in Ireland to have NCPs who are so accessible and helpful and we need to use this to our advantage. I didn't realise how fortunate we were until I spoke to my colleagues in other countries. Most of them have no idea who their NCP are and have certainly never met them'!

 

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