European Medicines Agency - Regulatory - Regulation of medicines

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INFANT - Irish Centre for Fetal and Neonatal Translational Research

Number of peer reviewed publications in the last 5 years 34 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 Ronit M Pressler, PhD*, Prof Geraldine B Boylan, PhD*, Prof Neil Marlow, DM, Prof Mats Blennow, MD, Catherine Chiron, PhD, Prof J Helen Cross, PhD, Prof Linda S de Vries, PhD, Boubou Hallberg, PhD, Prof Lena Hellström-Westas, PhD, Vincent Jullien, PhD, Vicki Livingstone, PhD, Barry Mangum, PharmD, Brendan Murphy, MD, Deirdre Murray, PhD, Gerard Pons, PhD, Janet Rennie, MD, Renate Swarte, PhD, Mona C Toet, PhD, Sampsa Vanhatalo, PhD, Sarah Zohar, PhD, for the NEonatal seizure treatment with Medication Off-patent (NEMO) consortium Lancet Neurol [Internet] Elsevier; 2015 Mar 23. Bumetanide for treatment of seizures in neonates Hannah C Glass Comment The Lancet Neurology Published Online: 09 March 2015 Seizures and hypothermia: Importance of electroencephalographic monitoring and considerations for treatment GB Boylan, L Kharoshankaya, CJ Wusthoff Seminars in Fetal and Neonatal Medicine 2015 (article in press): 1-6 Heart rate variability in hypoxic ischaemic encephalopathy: correlation with EEG grade and two-year neurodevelopmental outcome Goulding RM, Stevenson NJ, Murray DM, Livingstone V, Filan PM, Boylan GB. Pediatr Res [Internet]. International Pediatric Research Foundation, Inc.; 2015 Feb 9 The effect of organic anion transporter 3 inhibitor probenecid on bumetanide levels in the brain: an integrated in vivo microdialysis study in the rat Donovan MD, O’Brien FE, Boylan GB, Cryan JF, Griffin BT. J Pharm Pharmacol [Internet]. 2015 Clinical implementation of a neonatal seizure detection algorithm Temko A, Marnane W, Boylan G, Lightbody G. Decision Support Systems Volume 70, February 2015, Pages 86–96 Epilepsy after neonatal seizures: Literature review Pisani F, Facini C, Pavlidis E, Spagnoli C, Boylan G. European Journal of Paediatric Neurology Volume 19, Issue 1, January 2015, Pages 6–14 Metabolomic Profiling in Perinatal Asphyxia : A Promising New Field Denihan NM, Boylan GB, Murray DM. BioMed Research International Volume 2015, Article ID 254076, 9 page A longitudinal study of skin barrier function in pregnancy and the postnatal period Gallagher A, Hourihane JO’B, Kenny LC, Irvine AD, Khashan AS (2014). Obstetric Medicine, 7 (3) Predicting infant neurodevelopmental outcomes using the placenta? O’Keeffe GW, Kenny LC (2014).Trends In Molecular Medicine, 20 (6):303-305 Cohort profile: The Cork BASELINE birth cohort study: Babies after SCOPE: Evaluating the longitudinal impact on neurological and nutritional endpoints O’Donovan SM, Hourihane JO’B, Kenny LC, Murray DM, Irvine AD, Kiely M. (2014). International Journal of Epidemiology Neonatal seizure detection using atomic decomposition with a novel dictionary. Nagaraj SB, Stevenson NJ, Marnane WP, Boylan GB, Lightbody G. IEEE Trans Biomed Eng. 2014 Nov; 61(11):2724-32 Systematic review of neonatal seizure management strategies provides guidance on anti-epileptic treatment. Hellström-Westas L, Boylan G, Ågren J.Acta Paediatr. 2014. Early Postnatal EEG Features of Perinatal Arterial Ischaemic Stroke with Seizures Low E, Mathieson SR, Stevenson NJ, Livingstone V, Ryan CA, Bogue CO, et al. PLoS One. 2014;9(7):e100973. Neonatal EEG Audification for Seizure Detection. Temko A, Marnane W, Boylan G, O’Toole JM, Lightbody G IEEE EMBS International Conference on Engineering in Medicine and Biology, EMBC’14, Chicago, USA, August 2014. Modulation Frequency Analysis Of Seizures In Neonatal Eeg Temko A., Boylan GB, Marnane W. P., Lightbody G., EEE International Conference on Acoustics, Speech, and Signal Processing, ICASSP’14, Florence, Italy, May 2014. EEG ‘Diarization’ for the Description of Neonatal Brain Injuries Temko A., Marnane W., Boylan G, Lightbody G. IEEE International Conference on Acoustics, Speech, and Signal Processing, ICASSP’14, Florence, Italy, May 2014 A combined in vitro, in vivo and in silico approach to develop and optimise a novel antiepileptic strategy in neonatal seizures Donovan M, O’Brien FE, Boylan GB, Griffin BT, Cryan JF European Neuropsychopharmacology 2014 24 Supplement 1 S10 Global suppression of electrocortical activity in unilateral perinatal thalamic stroke. Kharoshankaya L., Filan P, Bogue C, Murray D, Boylan G Developmental Medicine and Child Neurology, 2014 Jan 11 Measuring brain activity cycling (BAC) in long term EEG monitoring of preterm babies. Stevenson N, Palmu K, Wikström S, Hellström-Westas L, Vanhatalo S, Physiological measurement, 2014; 35: p1493-1508 Cord blood proteins and multichannel-electroencephalography in hypoxic-ischemic encephalopathy Walsh, B. H.,Boylan, G. B.,Livingstone, V.,Kenny, L. C.,Dempsey, E. M.,Murray, D. M. (2013). Pediatric Critical Care Medicine, 14 (66):621-30 Clinical Prediction in Early Pregnancy of Infants Small for Gestational Age by Customised Birthweight Centiles: Findings from a Healthy Nulliparous Cohort McCowan, LME,Thompson, JMD,Taylor, RS,North, RA,Poston, L,Baker, PN,Myers, J,Roberts, CT,Dekker, GA,Simpson, NAB,Walker, JJ,Kenny, LC,SCOPE Consortium (2013). Plos One, 8 H-1 NMR Derived Metabolomic Profile of Neonatal Asphyxia in Umbilical Cord Serum: Implications for Hypoxic Ischemic Encephalopathy Reinke, SN,Walsh, BH,Boylan, GB,Sykes, BD,Kenny, LC,Murray, DM,Broadhurst, DI (2013). Journal of proteome research, 12 :4230-4239 EEG suppression associated with apneic episodes in a neonate. Low E, Dempsey EM, Ryan CA, Rennie JM, Boylan GB. Case Report Neurol Med.2012; 2012:250801. Association of nucleated red blood cells and severity of encephalopathy in normothermic and hypothermic infants. Walsh B, Boylan G, Dempsey E, Murray D. Acta Paediatrica, Volume 102, Issue 2, pages e64–e67, February 2013 An Automated System for Grading EEG Abnormality in Term Neonates with Hypoxic-Ischaemic Encephalopathy. Stevenson N. J., Korotchikova I., Temko A., Lightbody G., Marnane W. P., Boylan G. B. Annals of Biomedical Engineering. April 2013, Volume 41, Issue 4, pp 775-785. Monitoring neonatal seizures, Boylan GB, Stevenson NJ, Vanhatalo S, Seminars in Fetal and Neonatal Medicine 2013 Aug;18(4):202-8. The 1H-NMR Derived Metabolomic Profile of Neonatal Asphyxia in Umbilical Cord Serum: Implications for Hypoxic Ischaemic Encephalopathy Reinke SN, Walsh BH, Boylan GB, Sykes BD, Kenny LC, Murray DM, Broadhurst DI Journal of Proteome Research 2013 Sep 6;12(9):4230-9 Robust Neonatal EEG Seizure Detection Through Adaptive Background Modeling Temko A, Boylan G, Marnane W, Lightbody G International journal of neural systems Volume 23, Issue 04, August 2013 Normative Levels of Interleukin 16 in Umbilical Cord Blood Denihan NM, Looney AM, Boylan GB, Walsh BH, Murray DM Clinical biochemistry 2013 Dec;46(18):1857-9 Cord Blood Proteins and Multichannel-Electroencephalography in Hypoxic-Ischemic Encephalopathy* Walsh BH, Boylan GB, Livingstone V, Kenny LC, Dempsey EM, Murray DM Pediatric Critical Care Medicine 14 (6), 621-630 Neonatal seizures: The journey so far Boylan GB, Pressler R Seminars in Fetal and Neonatal Medicine 2013 Aug;18(4):173-4. Discriminative and generative classification techniques applied to automated neonatal seizure detection. Thomas E, Temko A, Marnane W, Boylan G, Lightbody G IEEE Journal of Biomedical and Health Informatics Vol/Issue: 17 (2), Date: 2013, Page: 297 ScrutiniseIT: A Search-Based Approach to EEG Seizure Detection O’Reilly RD, Power D, Healy PD, Morrison JP, Boylan GB eTELEMED 2013, The Fifth International Conference on eHealth, Telemedicine, and Social Medicine
Number of competitive grants obtained in the last 5 years 13 Depending on publication: listed Authors, biostatistical support, data collection, data analysis
Access to expert groups Yes Prof Geraldine Boylan Professor of Neonatal Physiology: Clinical trials sub-committee of the HPRA British Society of Clinical Neurophysiology Member European Neonatal Brain Club Elected Member European Society of Paediatric Research Member Irish Institute of Clinical Measurement Science Member Irish Institute of Clinical Neuroscience Member Physiological Society Member Irish Network of Medical Educators Member Electrophysiological Technologists Association Member Prof Eugene Dempsey Consultant Neonatologst: Faculty of Paediatrics Fellow Royal College of Physicians Fellow Irish Paediatric Association Member Irish Perinatal Society Member Irish American Paediatric Association President European Society for Paecitric Research Member European Society for Neonatology Member Dr Deidre Murray Consultant Paediatrician and Senior Lecturer : Faculty of Paediatrics Member European Neonatal Brain Club Elected Member Dr Brendan Murphy Consultant Neonatologist and senior Lecturer
Capacity to answer external scientific questions Yes We have expertise in the conduct of multi centre, multi national clinical trials and investigations particularly in neonates and this expertise is available for external consultation by contacting our Neonatal clinical trials coordinator Jackie O’Leary RGN, Diploma in Quality Management, BBUS and Masters in Clinical Trials. e-mail: Jackie.OLeary@ucc.ie
Site feasibility Yes
Participant recruitment Yes Each research project undertaken has a dedicated monitor/quality person.
Budget calculation for studies Yes We have a dedicated Finance manager