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NEMO Emergency Contact Details
 
emergency

Dear Collaborators,

Just a reminder that if you have any questions, big or small, we are only a phone call or email away . The NEMO EMERGENCY CONTACT DETAILS can be........

 


Dear Collaborators,

Just a reminder that if you have any questions, big or small, we are only a phone call or email away . The NEMO EMERGENCY CONTACT DETAILS can be found on the eCRF and office hours contact numbers and email addresses are below.

Chief Investigator
Dr Ronit Pressler

Office:+44 20 7813 8471 / 8488
ronit.pressler@gosh.nhs.uk

Co-PI
Prof Geraldine Boylan

Office: + 353 (0) 21 4201519
g.boylan@ucc.ie

NEMO Co-ordinator
Havinder Hara 
Office: + 44 (0)207 599 4102
h.hara@ucl.ac.uk

NEMO1 Study Monitor
Jackie O’Leary

Office: + 353 (0) 21 4205028
Jackie.oleary@ucc.ie

NEMO Cork Project Coordinator
Mairead Murray

Office: + 353 (0) 21 4205028
Mairead.Murray@ucc.ie

 eCRF- ClinInfo S.A
Dr Patrick Chevarier

Office: +44 (0) 2079052942
pch@clininfo.fr


EEG on call
NEMO EEG on call rota
 
On Call
The Nemo On Call EEG expert rota is available on the NEMO website for download as a pdf. An extract of the Rota is .......

The Nemo On Call EEG expert rota is available on the NEMO website for download as a pdf. An extract of the Rota is outlined below until the end of November 2012 and the instructions for contacting the expert on call. Firstly refer to the calendar to establish who the on-call Neurophysiologist is and to then make initial contact with the on-call Neurophysiologist advising that you require some advice for a NEMO EEG. The emergency contact numbers/details can be found on the eCRF

If the call goes unanswered please leave a message including your name and telephone number and try again shortly. Next ensure the relevant EEG tracing has been selected carefully. The EEG tracing should be anonymised and then uploaded via BabyLink (http://babylink.ucc.ie/). Please make a second call to the Neurophysiologist and discuss the results. In the event of any technical issues the Neurophysiologist should be notified.

Contact details for Neurophysiologists:


Prof. Geraldine Boylan: GB

Dr Ronit Pressler: RP
Dr Sampsa Vanhatalo: SV

 

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Feature Story
Welcome to the second issue of the NEMO newsletter
 
Ronit

This has been another productive and challenging year for the NEMO clinical trial sites. All active recruiting sites now have approval to restart and are looking or have just been granted approvals for protocol version 5.0. This huge achievement would not have been possible without the work of  Havinder, Vincent, Ronit, Geraldine and the PIs and study team at each site. I know that each site had individual issues that had to be resolved regarding submissions and approvals and that it is a major “milestone” that all these issues were resolved.


This has been another productive and challenging year for the NEMO clinical trial sites. All active recruiting sites now have approval to restart and are looking or have just been granted approvals for protocol version 5.0. This huge achievement would not have been possible without the work of  Havinder, Vincent, Ronit, Geraldine and the PIs and study team at each site. I know that each site had individual issues that had to be resolved regarding submissions and approvals and that it is a major “milestone” that all these issues were resolved.

All clinical sites have Competent Authority approvals in place for protocol version 4.0. Some sites have also been granted approvals protocol version 5.0, and the other sites are only waiting for the replies from their national authorities for version 5.0.

Reconciling all this documentation for the Investigator Site Files (ISF) and the Trial Management File (TMF) is a painstaking task for Havinder and Jackie but one completed with their usual throughness

We will hopefully be welcoming Tours and Kings College as active recruiting centres in the near future.

Best wishes
Ronit and Geraldine 


News and Views
NEMO meetings: An update
 
NEMO group
Just before the NEMO Meeting in Amsterdam scheduled for the 24th and 25th of September 2012 I would like to take the opportunity to remind you of the previous meeting of the NEMO PCC and PGB. As always the minutes of all meetings can be found on the milliarium website https://www.milliarium.gabo.de/Forms/Generic/Security/frmLogin.aspx

The Kick-off meeting in Cork (28-30 October 2009) was well attended with people from across the 16 centres. Participants were welcomed by the coordinator, Dr. Ronit Pressler and co-PI Dr Geraldine Boylan. The Scientific Officer, Dr. Fergal Donnelly welcomed all members on behalf of the European Commission and congratulated the consortium of NEMO on gaining the grant from the European Commission. He pointed out the importance of this project for the healthcare of children.

Just before the NEMO Meeting in Amsterdam scheduled for the 24th and 25th of September 2012 I would like to take the opportunity to remind you of the previous meeting of the NEMO PCC and PGB. As always the minutes of all meetings can be found on the milliarium website https://www.milliarium.gabo.de/Forms/Generic/Security/frmLogin.aspx

The Kick-off meeting in Cork (28-30 October 2009) was well attended with people from across the 16 centres. Participants were welcomed by the coordinator, Dr. Ronit Pressler and co-PI Dr Geraldine Boylan. The Scientific Officer, Dr. Fergal Donnelly welcomed all members on behalf of the European Commission and congratulated the consortium of NEMO on gaining the grant from the European Commission. He pointed out the importance of this project for the healthcare of children.

 Shortly before the 2nd meeting in London (7-9 April 2010 2nd PCC meeting) the NEMO project website went online on 6th April 2010. The website and its different sections were presented at this meeting by the project manager Judith and the consortium was informed that a project flyer was being developed by GABO:mi.

 The study website of the NEMO-1 study available at: www.nemo-study.com was presented at the meeting in Helsinki (26- 28 September 2010 Helsinki, 2nd PGB meeting). It was stressed that NEMO was one of the first consortiums within the FP7 framework program which included a US partner.

 The meeting in Marseille (11- 12 April 2011, 4th PCC meeting) addressed the first periodic report which has to be finalized by May 2011. The coordinator gave an update of the progress of the clinical trial, presenting the protocol changes and the current status of ethics and CTA submissions. An overview of all ethics and regulatory status was provided. SOP for Pharmacovigilence was ready for approval, The monitoring agreement also in place. Trial Master File Plan draft completed. It was expressed that the Green light for the opening of the first site is expected for the end of April 2011.

 At the meeting in Stockholm among others the Trial Steering Committee provided an update on status quo: the fact that the TSC Charter has been signed and a core TSC team named the Trial Management Committee has been established with biweekly meetings. The two sponsors GOSH and O4CP gave an update and shared inspection findings.

Attended by participants from across all the centres the meeting in Munich (19- 20 September 2011, 3rd PGB meeting) allowed a review of progress so far in the NEMO Clinical Trial. A key discussion focused on recruitment rate presented and it was agreed that the centres of Necker, IPP and Helsinki would be closed. There are two new potential centres University Hospital Tours in Lyon France and Kings College Hospital London UK. A clinical overview, a discussion on the SAE reporting process for NEMO and the recent DMC meeting and their response following the review was presented.

Milking collaborations!

Munich 2

Team building exercise!

Munich 3

I look forward to meeting you again at the meeting in Amsterdam and would like to take the opportunity to remind you that the meeting in Brussels is scheduled for April 25-26 2013 and the following meeting in Royaumont (near Paris CDG) is scheduled for September 23-24 2013.

Regards

Reka Török


NEMO Study Update
 
Havinder Hara

The NEMO consortium consists of 14 participating institutions based in seven different EU member states as well as one partner in the USA. The consortium is comprised of renowned researchers from all over Europe, each one with a strong scientific and/or clinical background in the fields of neonatology, neurophysiology, pharmacology or epilepsy.  One of the major aspects of this project is the NEMO study, and we are very proud to say that this study is being conducted to the highest ethical and regulatory standards.


The NEMO consortium consists of 14 participating institutions based in seven different EU member states as well as one partner in the USA. The consortium is comprised of renowned researchers from all over Europe, each one with a strong scientific and/or clinical background in the fields of neonatology, neurophysiology, pharmacology or epilepsy.  One of the major aspects of this project is the NEMO study, and we are very proud to say that this study is being conducted to the highest ethical and regulatory standards.

Since the project commenced the NEMO core trial office team have been meeting biweekly to discuss key issues relating to the conduct of the study. The core NEMO Trial office consists of University College Cork in Ireland, University College London in UK, Great Ormond Street Hospital NHS Trust also in the UK and Only for Children Pharmaceuticals.

On average it took each Investigational Centre around 4-8 months  to set up keeping in mind the variation of practices and languages within each Country.  Once the Centres received approval, the study monitor performed an initiation visit in line with the relevant legislation and in adherence to NEMO policies and SOPs. What’s unique about this Investigator Led project is the standard of processes applied throughout the trial.

At present the NEMO clinical trial is in full operation and the first three centres were given green light to commence recruitment on 11th August 2011. The first baby enrolled was recruited on 9th October 11 and was enrolled by Karolinska Instituet in Sweden which is a very big milestone and the baby was recruited without any problems. There after further babies were enrolled across the other centres.  On the whole recruitment has been very slow to say the least but there are some underlying reasons for this. The Investigator’s have also been very co-operative and have demonstrated a high degree of precision when collecting and recording data into the electronic case report form (eCRF). The Investigators and site staff have formed excellent relationships with the NEMO Trial Office team and it can be said its truly remarkable. At present recruitment is planned to end in November 2012 we will be contacting the Investigators closer to this date.

The successful execution of the NEMO study to date is based on the careful planning by the NEMO trial office and with full co-operation of the Investigator sites.  We are delighted with the progress of NEMO so far and will continue to assist the sites with this study.

NEMO Centres

The study is being conducted in 7 sites across 5 countries and the Sites are as follows:Cork University Maternity Hospital, University Medical Centre Utrecht , Leeds General Infirmary, Karolinska Instituet and Univ. Hospital KIUH Solna, UCLH NHS Foundation Trust, Uppsala University Hospital, Erasmus Universitair Medisch Centrum- Rotterdam.

The NEMO Trial office team would like to thank the Investigational sites for their valuable participation. If anyone would like to any further information please feel free to contact us.

We Value Your Opinion!


Publications
Publications
Recent publications of group members

Just to prove there is life outside of NEMO or at least that you manage to get something done in-between all the paperwork,.......


Just to prove there is life outside of NEMO or at least that you manage to get something done in-between all the paperwork, and yes it is necessary and no GCP is not a swear word. We would like to bring you a very small selection of recent publications from NEMO collaborators in no particular order. This is a very small selection as we would never have room for all the recent papers abstracts and articles. Congratulations everyone on the many papers recently published and the hard work that went into each and every one of these.

Arch Dis Child Fetal Neonatal Ed. 2012 Sep;97(5):F318-22.
Outcomes at 7 years for babies who developed neonatal necrotising enterocolitis: the ORACLE Children Study.
Pike K, Brocklehurst P, Jones D, Kenyon S, Salt A, Taylor D, Marlow N.
http://www.ncbi.nlm.nih.gov/pubmed/22933088

Cereb Cortex. 2012 Mar 7. [Epub ahead of print]
Early Development of Spatial Patterns of Power-Law Frequency Scaling in fMRI Resting-State and EEG Data in the Newborn Brain.
Fransson P, Metsäranta M, Blennow M, Aden U, Lagercrantz H, Vanhatalo S.
http://www.ncbi.nlm.nih.gov/pubmed/22402348

Acta Obstet Gynecol Scand. 2012 Aug 22. doi: 10.1111/j.1600-0412.2012.01530.x. [Epub ahead of print]
Effects of delayed compared to early umbilical cord clamping on maternal postpartum hemorrhage and cord blood gas sampling: a randomized trial.
Andersson O, Hellström-Westas L, Andersson D, Clausen J, Domellöf M.
http://www.ncbi.nlm.nih.gov/pubmed/22913332

J Pediatr. 2012 Aug 18. [Epub ahead of print]
Neurologic Assessment Tool for Screening Preterm Infants at Term Age.Romeo DM, Ricci D, van Haastert IC, de Vries LS, Haataja L, Brogna C, Gallini F, Romagnoli C, Cowan FM, Mercuri E. http://www.ncbi.nlm.nih.gov/pubmed/22910101

PLoS One. 2012;7(2):e31543. Epub 2012 Feb 21.
Long-range temporal correlations in the EEG bursts of human preterm babies.
Hartley C, Berthouze L, Mathieson SR, Boylan GB, Rennie JM, Marlow N, Farmer SF http://www.ncbi.nlm.nih.gov/pubmed/22363669

Pediatrics. 2012 Aug;130(2):e451-5. Epub 2012 Jul 2.
Recooling for rebound seizures after rewarming in neonatal encephalopathy.
Kendall GS, Mathieson S, Meek J, Rennie JM
http://www.ncbi.nlm.nih.gov/pubmed/22753564

Semin Fetal Neonatal Med. 2012 Jul 25. [Epub ahead of print]
Long-term outcome of antenatally diagnosed agenesis of corpus callosum and cerebellar malformations.
Vasudevan C, McKechnie L, Levene M
http://www.ncbi.nlm.nih.gov/pubmed/22840681

Clin Neurophysiol. 2012 Jun 28. [Epub ahead of print]
Evoked magnetic fields from primary and secondary somatosensory cortices: A reliable tool for assessment of cortical processing in the neonatal period.
Nevalainen P, Pihko E, Metsäranta M, Sambeth A, Wikström H, Okada Y, Autti T, Lauronen L.
http://www.ncbi.nlm.nih.gov/pubmed/22749463

Acta Paediatr. 2012 Aug;101(8):e378-81. doi: 10.1111/j.1651-2227.2012.02724.x. Epub 2012 May 29.
SurePrep, an easy alternative for skin preparation in neonatal EEG monitoring.
Sinisalo L, Mäki J, Stjerna S, Vanhatalo S.
http://www.ncbi.nlm.nih.gov/pubmed/22568529

Antimicrob Agents Chemother. 2012 Sep 4. [Epub ahead of print]
High-throughput sequencing reveals the incomplete, short-term, recovery of the infant gut microbiota following parenteral antibiotic treatment with ampicillin and gentamycin.
Fouhy F, Guinane CM, Hussey S, Wall R, Ryan CA, Dempsey EM, Murphy B, Ross RP, Fitzgerald GF, Stanton C, Cotter PD
http://www.ncbi.nlm.nih.gov/pubmed/22948872

Hum Brain Mapp. 2012 Apr 21. doi: 10.1002/hbm.22076. [Epub ahead of print]
Relationship of EEG sources of neonatal seizures to acute perinatal brain lesions seen on MRI: A pilot study.
Despotovic I, Cherian PJ, De Vos M, Hallez H, Deburchgraeve W, Govaert P, Lequin M, Visser GH, Swarte RM, Vansteenkiste E, Van Huffel S, Philips W
http://www.ncbi.nlm.nih.gov/pubmed/22522744

J Pediatr. 2012 Apr;160(4):559-566.e1. Epub 2011 Nov 4.
Neonatal magnetic resonance imaging and outcome at age 30 months in extremely preterm infants.
Skiöld B, Vollmer B, Böhm B, Hallberg B, Horsch S, Mosskin M, Lagercrantz H, Ådén U, Blennow M. http://www.ncbi.nlm.nih.gov/pubmed/22056283

Front Cell Neurosci. 2012;6:35. Epub 2012 Aug 28.
Refuting the challenges of the developmental shift of polarity of GABA actions: GABA more exciting than ever!
Ben-Ari Y, Woodin MA, Sernagor E, Cancedda L, Vinay L, Rivera C, Legendre P, Luhmann HJ, Bordey A, Wenner P, Fukuda A, van den Pol AN, Gaiarsa JL, Cherubini E. http://www.ncbi.nlm.nih.gov/pubmed/22973192

Dev Med Child Neurol. 2012 Sep;54(9):782-3. doi: 10.1111/j.1469-8749.2012.04376.x. Epub 2012 Jul 17.
Vagus nerve stimulation in children with intractable epilepsy.
Pressler RM.
http://www.ncbi.nlm.nih.gov/pubmed/22803764

Antimicrob Agents Chemother. 2012 Aug 27. [Epub ahead of print]
Population pharmacokinetic and pharmacodynamic modeling of amodiaquine and desethylamodiaquine in women with Plasmodium vivax malaria during and after pregnancy.
Tarning J, Chotsiri P, Jullien V, Rijken MJ, Bergstrand M, Cammas M, McGready R, Singhasivanon P, Day NP, White NJ, Nosten F, Lindegardh N
http://www.ncbi.nlm.nih.gov/pubmed/22926572

Cortex. 2012 Jul 16. [Epub ahead of print]
Impaired emotional memory recognition after early temporal lobe epilepsy surgery: The fearful face exception?
Pinabiaux C, Bulteau C, Fohlen M, Dorfmüller G, Chiron C, Hertz-Pannier L, Delalande O, Jambaqué I.
http://www.ncbi.nlm.nih.gov/pubmed/22901711




Meet The Team
Collaborator’s interview- Dr Deirdre Murray
Meet the Team

How did you first become involved in research?
When I was doing the Surgeon Noonan elective in 4th Med, I looked at what symptoms predicted a positive HIV test in the children .......


How did you first become involved in research?
When I was doing the Surgeon Noonan elective in 4th Med, I looked at what symptoms predicted a positive HIV test in the children attending our clinics in
Zimbabwe. The HIV incidence of 20% of the population was a shock to the three girls from Cork. That gave me a taste for research which I have never lost.

What is the main focus of your research now?
Early brain injury and neurodevelopmental outcome. We have been really lucky in being able to develop a unique birth cohort here in
Cork which we hope will answer many questions in the field of allergy, growth and development. With the Neonatal Brain Research Group, I have been trying to find an early and reliable biomarker for predicting outcome in hypoxic-ischaemic encephalopathy. Professor Geraldine Boylan has been a fantastic mentor and colleague.

What has been the most interesting aspect of your career to date?
Clinically, the 12 months that I spent doing paediatric retrievals in the Royal Children’s Hospital in
Melbourne was unforgettable. The day might include a late evening helicopter trip past the Twelve Apostles and landing in a football field in rural Victoria to stabilise an injured child. This could be quickly followed by a night-time fixed wing aircraft flight to the bush for the next patient in need. We had to think fast and stay calm. I met rural GPs who acted as extremely effective obstetricians, anaesthetists and neonatologists to mother and child. The paediatric intensivists of the RCH in Melbourne are all I need for inspiration when I’m at a loss. 

How do you think research has changed in Cork over the years?
I can only speak for Paediatrics, but our research landscape has changed dramatically in the last 8-10 years. There are many more post-graduate students completing higher degrees, PhDs in particular. We have seen the development of the Anu Research Centre, the Neonatal Brain Research Centre and the HRB Children’s Discovery Centre. There is a lot more interaction between basic science/ engineering and clinical researchers. This is what we have to do. We need to use the rapidly developing technologies to help our patients. We are also much more involved in international multicentre trials. Again, this is essential in Paediatrics as we are often studying relatively rare diseases.

Is it becoming more difficult to carry out research as financial grants are becoming less available?
We have been lucky so far, and I have fantastic colleagues in the Department of Paediatrics. We have been able to grow our research in many areas. Translational research is more important than ever for our economy and so I think you need the combination of innovative research methods and clinical relevance to be successful.

What do you think has made the most dramatic impact on health and well-being?
For Paediatrics, as clinicians we have put our hands up and admitted that really it is public health and epidemiology that have made the biggest differences. Clean water, vaccinations and the Back to Sleep initiative have saved more lives than anything else.

What advice would you give to any medical students interested in research?
Go for it!

What do you think is the most interesting part of research?
When you look at a clinical situation and see an unanswered question. Then you think, I could find that out, and you work out a way of answering the question.  The thought that you could improve the knowledge base or management of a clinical problem is what it is all about.

What do you think is unique to research as opposed to clinical medicine?
I think you can’t have one without the other. Clinical problems drive clinical medicine and vice versa. If you separate them, neither will develop.

What career could you see yourself in besides medicine?
Don’t laugh, but I have dreams of going back to study art and ceramics. I don’t know if I would be any good, or make any money, but I always loved it.

What has been the most exciting place you have visited?
As a tourist, canoeing to
Angel Falls in Venezuela was a great adventure. As a doctor, I worked in South Sudan, about 40 miles behind the frontline with the tribal Dinka people. This was exciting at times, but mostly humbling, and it definitely changed my perspective on life. 

What do you do for fun or to relax?
Relaxing is making pancakes for the kids on a Saturday morning before we start the runs to football/hurling etc. With three kids, I don’t get a lot of time to relax, but when I get the chance, I like to get out and go for a run to clear out thoughts of work for a while.

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