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The Amsterdam PGB meeting
 

The Amsterdam Project Governing Board meeting took place on the 24th and 25th of September 2012 and was well attended by participants. A variety of issues were addressed: A review of the data for the patients enrolled so far was analysed and discussed and case studies from two recruiting centres in Cork and Rotterdam were presented. 


The Amsterdam Project Governing Board meeting took place on the 24th and 25th of September 2012 and was well attended by participants. A variety of issues were addressed: A review of the data for the patients enrolled so far was analysed and discussed and case studies from two recruiting centres in Cork and Rotterdam were presented. Furthermore, the data from an internal EEG interim analysis was presented to the group. A representative of the Pharma company SOBI also attended the meeting. The meeting on the 24th ended with a bus tour through the city followed by a reception and dinner at the NEMO Science Museum.

           

Side Articles
Some recent publications
Life outside of NEMO continues......

Life outside of NEMO continues as indicated by this short list of some of the many recent publications from the NEMO collaborators......

Outcome following neonatal seizures. Uria-Avellanal C, Marlow N, Rennie JM. Semin Fetal Neonatal Med. 2013 Feb 25.
http://www.ncbi.nlm.nih.gov/pubmed/23466296 

Early neurophysiology and MRI in predicting neurological outcome at 9-10years after birth asphyxia. Kontio T, Toet MC, Hellström-Westas L, van Handel M, Groenendaal F, Stjerna S, Vanhatalo S, de Vries LS. Clin Neurophysiol. 2013 Feb 8.
http://www.ncbi.nlm.nih.gov/pubmed/23403266

Cortical somatosensory processing measured by magnetoencephalography predicts neurodevelopment in extremely low gestational age infants. Rahkonen P, Nevalainen P, Lauronen L, Pihko E, Lano A, Vanhatalo S, Pesonen AK, Heinonen K, Räikkönen K, Valanne L, Autti T, Andersson S, Metsäranta M. Pediatr Res. 2013 Mar 11.
http://www.ncbi.nlm.nih.gov/pubmed/23478643

Neonatal thalamic hemorrhage is strongly associated with electrical status epilepticus in slow wave sleep. Kersbergen KJ, de Vries LS, Leijten FS, Braun KP, Nievelstein RA, Groenendaal F, Benders MJ, Jansen FE. Epilepsia. 2013 Mar 18.
http://www.ncbi.nlm.nih.gov/pubmed/23506484

The metabolomic profile of umbilical cord blood in neonatal hypoxic ischaemic encephalopathy. Walsh BH, Broadhurst DI, Mandal R, Wishart DS, Boylan GB, Kenny LC, Murray DM. PLoS One. 2012;7(12):e50520.
http://www.ncbi.nlm.nih.gov/pubmed/23227182

 Outcome following neonatal seizures. Uria-Avellanal C, Marlow N, Rennie JM. Semin Fetal Neonatal Med. 2013 Feb 25.
http://www.ncbi.nlm.nih.gov/pubmed/23466296

Planned home birth: the professional responsibility response. Chervenak FA, McCullough LB, Brent RL, Levene MI, Arabin B. Am J Obstet Gynecol. 2013 Jan;208(1):31-8.
http://www.ncbi.nlm.nih.gov/pubmed/23151491

 Automated EEG inter-burst interval detection in neonates with mild to moderate postasphyxial encephalopathy. Matic V, Cherian PJ, Jansen K, Koolen N, Naulaers G, Swarte RM, Govaert P, Visser GH, Van Huffel S, De Vos M. Conf Proc IEEE Eng Med Biol Soc. 2012 Aug;2012:17-20.
http://www.ncbi.nlm.nih.gov/pubmed/23365821

Initial results from the newborn hearing screening programme in Ireland. O'Connor A, O'Sullivan PG, Behan L, Norman G, Murphy B. Ir J Med Sci. 2013 Mar 2.
http://www.ncbi.nlm.nih.gov/pubmed/23456183

Investigating the European perspective of neonatal point-of-care echocardiography in the neonatal intensive care unit-a pilot study. Roehr CC, Te Pas AB, Dold SK, Breindahl M, Blennow M, Rüdiger M, Gupta S. Eur J Pediatr. 2013 Feb 26.
http://www.ncbi.nlm.nih.gov/pubmed/23440477

Differing attitudes toward phenobarbital use in the neonatal period among neonatologists and child neurologists in Sweden. Wickström R, Hallberg B, Bartocci M. Eur J Paediatr Neurol. 2013 Jan;17(1):55-63.
http://www.ncbi.nlm.nih.gov/pubmed/23000057

Pioneer glutamatergic cells develop into a morpho-functionally distinct population in the juvenile CA3 hippocampus. Marissal T, Bonifazi P, Picardo MA, Nardou R, Petit LF, Baude A, Fishell GJ, Ben-Ari Y, Cossart R. Nat Commun. 2012;3:1316.
http://www.ncbi.nlm.nih.gov/pubmed/23271650

A revisited strategy for antiepileptic drug development in children : designing an initial exploratory step. Chiron C, Kassai B, Dulac O, Pons G, Nabbout R. CNS Drugs. 2013 Mar;27(3):185-95.
http://www.ncbi.nlm.nih.gov/pubmed/23345029


Information
NEMO PCC Meeting in Brussels
 

The NEMO PCC Meeting on the 25th and 26th of April will be held in Hotel Bloom! Rue Royale 250, 1210 Brussels – Belgium | T: +32 (0)2 220 66 11 Just 20 meters away from a Metro station, trams and buses at “Botanique” station on Metro line 2 or 6. Nearest rail connection is at Gare du Nord/North Station (500 meters).
http://www.hotelbloom.com/hotel/default-en.html 
Please find more directions and information below....


The NEMO PCC Meeting on the 25th and 26th of April will be held in Hotel Bloom! Rue Royale 250, 1210 Brussels – Belgium | T: +32 (0)2 220 66 11 Just 20 meters away from a Metro station, trams and buses at “Botanique” station on Metro line 2 or 6. Nearest rail connection is at Gare du Nord/North Station (500 meters).
http://www.hotelbloom.com/hotel/default-en.html 
Please find more directions and information below....

 From Brussels Airport to Hotel Bloom

  • Taxi: Brussels Airport at 12 km or 25 minutes by taxi with normal traffic (around 40€)
  • Train: Airport City Express trains go to Brussels' three main stations (Brussels Central, Brussels North and Brussels Midi (journey time: 16-25 minutes, fare €5.40).From Brussels Midi (Gare du Midi) you can take the direct line 2 or 6 both Simonis (Elisabeth) and get off at Botanique/Kruidtuir (final destination). The price for a single metro ticket is €1.90 and allows you to change the lines.
  • Bus: express bus line from Schuman station to Brussels Airport

 From Thalys or Eurostar to Hotel Bloom

Thalys and Eurostar station: Gare du Midi/South Station at 3 kms (reachable by metro) - metro line 2 or 6 from the South Station to Botanique

 Metro:

  • From Brussels Midi (Gare du Midi) you can take the direct line 2 or 6 both Simonis (Elisabeth) and get off at Botanique/Kruidtuir (final destination). The price for a single metro ticket is 1,90€ and allows you to change the lines.
  • From Brussels Central (Gare Centrale) take the yellow line 5 in direction Hermann Debroux and get off at Arts-Loi/Kunst-Wet. At Arts-Loi/Kunst-Wet change to line 2 or 6 both Simonis (Elisabeth) and get off at Botanique/Kruidtuir (final destination).  


Click to download Brussels Metro map


Feature Story
Welcome
 

Dear NEMO collaborators,

Welcome to the third issue of the NEMO newsletter. A lot has changed since the last issue of the newsletter and we wish to thank you all for the work involved in these changes. Since the last PGB meeting in Amsterdam in September 2012 a decision was made for an early termination of the NEMO-1 study, this was not an easy decision to come to but we all agreed that it was the right decision to make. We look forward to NEMO-2 and hope that the experience gained during NEMO-1 will make this a much easier process.

On a sadder note we say good bye to Havinder Hara our clinical trial coordinator, who is moving to a new position. We wish to thank Havinder for all the hard work she put into NEMO-1 and wish her the best of luck for the future.

Best wishes and looking forward to seeing you in Brussels

Geraldine and Ronit



News and Views
Trial Update
 
Hara HiRes
The NEMO trial is a pan European Multicentre clinical trial conducted across 6 Member States. The trial received its first “green Light” to start recruitment in August 2011 and the first participant was enrolled in October 2011. Since the project commenced the NEMO core trial office team have met on a regular basis to discuss study related issues and offer support to the clinical trial site . The NEMO core trial office members are a unique partnership of UCC, GOSH, O4CP and UCL. This partnership spans four languages, three countries and two time zones making for some interesting meetings.

The NEMO trial is a pan European Multicentre clinical trial conducted across 6 Member States. The trial received its first “green Light” to start recruitment in August 2011 and the first participant was enrolled in October 2011. Since the project commenced the NEMO core trial office team have met on a regular basis to discuss study related issues and offer support to the clinical trial site . The NEMO core trial office members are a unique partnership of UCC, GOSH, O4CP and UCL. This partnership spans four languages, three countries and two time zones making for some interesting meetings.

Staff at all the clinical trial sites have shown great dedication and great effort to make this study work. Despite this recruitment to the trial has been difficult for various reasons. There is no question that the logistics of this trial have been challenging for the clinical sites and we can only hope that the trial office has been as supportive as possible to match the dedication of everybody involved.  The Trial Steering committee met in November 2012 and agreed, after an analysis of the trial data already collected that an early termination should be next step for the NEMO-1 study and the relevant authorities in each relevant Member State were notified. The study monitor has visited all the clinical trial sites and conducted a “study close out visit.” A date for database lock was also proposed and this has just recently been achieved.

Taking into account the various legislative requirements and local practices within each Member State the greatest achievement of NEMO-1 has been the successful recruitment of patients, across Europe, into a neonatal study in an intensive care setting. The NEMO consortium consisting of researchers with a strong scientific and/or clinical background in the fields of neonatology, neurophysiology, pharmacology or epilepsy clinicians across Europe and USA has proven to be a strong collaboration capable of conducting research to the highest standards. Working with the consortium been most rewarding and their collaborative approach is an excellent accomplishment.

The NEMO study has been conducted to the highest ethical and regulatory standards and it is clearly evident at all times that the trial personnel have felt the heat of the need for ensuring documentation is completed accurately and filed accordingly. The Core NEMO trial office would like to thank and congratulate all the Investigators and their research teams for their exceptional work to ensure the successful execution of this trial. The next phase of the project is being discussed at present and we hope that NEMO-2 will be agreed on at the upcoming meeting in Brussels in April.    

The NEMO Centres
The study has been conducted in 10 sites across 6 countries and the Sites are as follows:
Sweden: Karolinska Instituet and Univ. Hospital KIUH Solna and Uppsala University Hospital
Ireland: Cork University Maternity Hospital
The Netherlands: University Medical Centre Utrecht and Erasmus Universitair Medisch Centrum- Rotterdam
UK:  Leeds General Infirmary and University College London Hospital (UCLH) NHS Foundation Trust
Finland: Helsinki University Central Hospital
France: Hospital Necker-Enfants Malades, Paris and Institut de Puericultur, Paris

 If anyone would like to any further information please feel free to contact us.We Value Your Opinion!  If you have any feedback to share about the newsletter or the study in general, please contact any member of the study team.

Useful Contacts,
UCC
Jackie O’Leary (Study monitor) Jackie.oleary@ucc.ie
Mairead Murray (Project manager Cork) mairead.murray@ucc.ie
UCL
Ronit Pressler (Chief Investigator) Ronit.pressler@gosh.nhs.uk

 


Meet The Team
Ms Jackie "The Whip" O'Leary

Getting to know the NEMO team, some quick questions and answers from Ms Jackie O’Leary


Getting to know the NEMO team, some quick questions and answers from Ms Jackie O’Leary

1.         Favourite food? Chicken
2.         Favourite place? After Clonakilty, Co. Cork (my home town) then Dingle Co Kerry
3.         Do you have a pet? 1 Dog 1 Cat 1 Husband
4.         Best holiday? Interrailing through Europe with the person who always does what he is told...my husband
5.         Favourite movie? Pretty Woman
6.         Ideal Sunday morning? Can't Say!!!
7.         If you didn’t live in Ireland, where else would you like to live? San Francisco
8.         Cooking for friends – what do you cook?  Beef Stroganoff
9.         Stuck in the lift – alone or with others? Oh definitely with others
10.       Favourite book? The monitor's manual to ICH-GCP guidelines and auditing....not!
11.       Chocolate or sweets? Neither, see below
12.       Guilty pleasure? Copious amounts of vodka!
13.       Best Christmas? At home with family and loads of children
14.       Sun or snow holiday? Sun
15.       Favourite room? Kitchen
16.       Famous last words? Love you bye
17.       Black tie or disco? Black Tie
18.       Favourite colour? Black
19.       Favourite tipple Vodka of course
20.       Treadmill, cross-trainer or couch? Treadmill

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