Objective Neonatal hypoxic ischaemic encephalopathy (HIE) occurs in 2-3/1000 live births and is a major cause of both acute mortality and long-term neurodisability. Seizures are the hallmark of HIE. The clinical and electrographic seizure burden in babies with HIE can be considerable and is often not reduced by current antiepileptic drugs. Phenobarbitone remains the first line drug for neonatal seizures despite the fact that it has limited efficacy. Better treatments for neonatal seizures, particularly in asphyxiated babies, are a high research priority with the ultimate aim to improve long-term outcome.The aim of NEMO is to develop an effective treatment regimen for neonatal seizures using innovative strategies, targeted specifically to the needs and peculiarities of babies. An age dependent high expression of neuronal co-transporter resulting in excitatory rather than inhibitory function of GABA is believed to be responsible for the high incidence of seizures in the neonatal period. By blocking this co-transporter with bumetanide, a loop diuretic, the depolarizing action of GABA will be reversed resulting in reduced neuronal firing. Intensive EEG monitoring will enable us to accurately identify seizures and monitor treatment effect. A European-wide multicentre approach would, for the first time facilitate performing an RCT with enough statistical power in this age-group.By consolidating efforts from basic science, pharmacology and clinical centres we propose:1. to perform a European-wide, multicentre, randomised, placebo-controlled, double-blind trial to evaluate the efficacy and safety of bumetanide in neonates2. to perform pharmacokinetic and pharmacodynamic studies of bumetanide3. to further investigate the mechanisms of action in non-clinical experiments4. to develop and adapt a bumetanide formulation suitable for neonates in order to apply for a Paediatric Use Marketing Authorization (PUMA).5. if results of the initial trial do not support a PUMA application we plan to apply for a Paediatric Investigation Plan (PIP) for lidoocaine to assess its efficacy as an AED for the control of seizures which are not controlled by phenobarbitone. Fields of science social sciencessociologydemographymortalitymedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsmedical and health sciencesclinical medicinepaediatrics Keywords Neonatal seizures PK/PD bumetanide drug development off-patent randomised controlled trial Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2009-4.2-1 - Adapting off-patent medicines to the specific needs of paediatric populations Call for proposal FP7-HEALTH-2009-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator UNIVERSITY COLLEGE LONDON EU contribution € 926 970,00 Address GOWER STREET WC1E 6BT LONDON See on map Activity type Higher or Secondary Education Establishments Administrative Contact Greta Borg-Carbott (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (14) Sort alphabetically Sort by EU Contribution Expand all Collapse all UNIVERSITY COLLEGE CORK - NATIONAL UNIVERSITY OF IRELAND, CORK Ireland EU contribution € 1 212 648,00 Address WESTERN ROAD T12 YN60 Cork See on map Region Ireland Southern South-East Activity type Higher or Secondary Education Establishments Administrative Contact Mary Cusack (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE France EU contribution € 565 685,00 Address RUE DE TOLBIAC 101 75654 Paris See on map Region Ile-de-France Ile-de-France Paris Activity type Research Organisations Administrative Contact Annick Bertault (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data HUS-YHTYMA Finland EU contribution € 228 409,00 Address STENBACKINKATU 9 00029 Helsinki See on map Region Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa Activity type Research Organisations Administrative Contact Anne Karikumpu (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITY OF LEEDS United Kingdom EU contribution € 183 072,00 Address WOODHOUSE LANE LS2 9JT Leeds See on map Region Yorkshire and the Humber West Yorkshire Leeds Activity type Higher or Secondary Education Establishments Administrative Contact Kathy Brownridge (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UPPSALA UNIVERSITET Sweden EU contribution € 191 220,00 Address VON KRAEMERS ALLE 4 751 05 Uppsala See on map Region Östra Sverige Östra Mellansverige Uppsala län Activity type Higher or Secondary Education Establishments Administrative Contact Inga Andersson (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data GABO:MI GESELLSCHAFT FUR ABLAUFORGANISATION:MILLIARIUM MBH & CO KG Germany EU contribution € 367 800,00 Address OSKAR VON MILLER RING 29 80333 Muenchen See on map Region Bayern Oberbayern München, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Birgit Fuchs (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Only For Children Pharmaceuticals Participation ended France EU contribution € 742 214,04 Address Rue Henri Barbusse 35 bis 75005 Paris See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Vincent Grek (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITAIR MEDISCH CENTRUM UTRECHT Netherlands EU contribution € 307 362,00 Address HEIDELBERGLAAN 100 3584 CX Utrecht See on map Region West-Nederland Utrecht Utrecht Activity type Higher or Secondary Education Establishments Administrative Contact Margot Van Der Starre (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ASSISTANCE PUBLIQUE HOPITAUX DE PARIS France EU contribution € 74 855,00 Address 55 BOULEVARD DIDEROT 75012 Paris See on map Region Ile-de-France Ile-de-France Val-de-Marne Activity type Research Organisations Administrative Contact Christophe Misse (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data DUKE UNIVERSITY United States EU contribution € 108 160,00 Address ALLEN BUILDING 207 27708 Durham Nc See on map Activity type Higher or Secondary Education Establishments Administrative Contact Oshrat Benmoshe-Doriocourt (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data KAROLINSKA INSTITUTET Sweden EU contribution € 164 040,00 Address Nobels Vag 5 17177 Stockholm See on map Region Östra Sverige Stockholm Stockholms län Activity type Higher or Secondary Education Establishments Administrative Contact Rolf Trana (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CLININFO S.A. France EU contribution € 76 575,00 Address RUE DE GERLAND- ENTREE 7 99 69007 LYON See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Corinne Chevarier (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST United Kingdom EU contribution € 140 103,60 Address GREAT ORMOND STREET WC1N 3JH London See on map Region London Inner London — West Camden and City of London Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Jo Southern (Dr.) Links Contact the organisation Opens in new window Total cost No data ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Netherlands EU contribution € 81 689,00 Address DR MOLEWATERPLEIN 40 3015 GD Rotterdam See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Sandra Horsch (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data
