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.

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!

Rate: 12345 (0) | Facebook Twitter LinkedIn Del.icio.us Digg | Post a comment
Post a comment
Name:

Comment:

In This Issue
Information
NEMO Emergency Contact Details
EEG on call
Feature Story
Welcome to the second issue of the NEMO newsletter
News and Views
NEMO meetings: An update
NEMO Study Update
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,.......

Read more
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 .......

Read more
Useful Links
Nemo Europe
NEMO Study
Milliarium
FP7
Seventh Framework Programme

NEMO is a Collaborative Project funded by the European Commission under the 7th Framework Programme
Email Software by Newsweaver