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No pain during infancy by adapting off-patent medicines

Start date:2008-10-01

End date:2013-09-30

Project Acronym:NEOOPIOID

Project status:Execution

Coordinator

Organization name:KAROLINSKA INSTITUTET
Administrative contact Address
Name:Thomas WALSTAM (Mr) Nobels Vag 5

STOCKHOLM
SVERIGE

Region:SVERIGE STOCKHOLM
Tel:+46-852488400
Fax:+46-851771774
E-mail:Contact
URL:http://www.ki.se Organization Type:Education

Description


Objective: Preterm and newborn infant may suffer from pain in the same way as adults. They are even more sensitive to pain due to immaturity of endogenous modulation. Thus, they should have the same human right to be alleviated from pain. The overall aim of this project is to assess effects and safety of opioid treatment in very preterm up to full term newborn infants in relation to pharmacokinetics predisposition. Furthermore, a major goal is to develop a PUMA for safe administration of opioid analgesic treatment in newborn infant. Both morphine and fentanyl are off-labelled (EMEA) drugs. Several studies have shown that opioid treatment in newborn reduce pain and stress responses. However, these drugs also have side-effects related to plasma concentrations of the drugs and their metabolites. The new approach in the current project is to obtain a more personalized drug therapy to the newborn infant, and to consider individual differences in pharmacokinetics, as well as gender effects. We will perform a multinational European survey of practices regarding sedation and analgesia in neonatal units. Clinical multicenter trial evaluating safety aspects of morphine and fentanyl will be performed. The responses (evaluated with validated pain scales) will be related to pharmacokinetics predisposition. A

Achievements:

General information:

Project Details


Start date:2008-10-01

End date:2013-09-30

Duration:60 months

Project Reference:223767

Project cost:2881489 EURO

Project Funding:2299164 EURO

Programme Acronym: FP7-HEALTH

Programme type:Seventh Framework Programme

Subprogramme Area:Adapting off-patent medicines to the specific needs of paediatric populations

Contract type:Small or medium-scale focused research project

URL:

Subject index:Social Aspects, Medicine, Health

Other Indexes:pain,pharmacokinetics,Newborn,preterm,analgesia morpjine
 

Results for this Project

Periodic Report Summary - NEOOPIOID (No pain during infancy by adapting off-patent medicines)  23/07/2012 

Other participants

Organization name:THE UNIVERSITY OF EDINBURGH
Administrative contact Address
Name:Angela NOBLE (Ms.) OLD COLLEGE, SOUTH BRIDGE

EDINBURGH
UNITED KINGDOM

Region:SCOTLAND BORDERS-CENTRAL-FIFE-LOTHIAN-TAYSIDE Lothian
Tel:+44-1316509024
Fax:+44-1316509023
E-mail:Contact
URL:http://www.ed.ac.uk Organization Type:Education
 
Organization name:UNIVERSITY OF LEICESTER
Administrative contact Address
Name:Marie SINGER (Ms.) University Road

LEICESTER
UNITED KINGDOM

Region:EAST MIDLANDS LEICESTERSHIRE, NORTHAMPTONSHIRE Leicestershire
Tel:+44-1162231799
Fax:+44-1162522028
E-mail:Contact
URL:http://www.le.ac.uk Organization Type:Education
 
Organization name:UNIVERSITEIT ANTWERPEN
Administrative contact Address
Name:Anne ADAMS (Ms.) PRINSSTRAAT 13

ANTWERPEN
BELGIQUE-BELGIË

Region:VLAAMS GEWEST ANTWERPEN Antwerpen (Arrondissement)
Tel:+32-32653028
Fax:+32-32653011
E-mail:Contact
URL:http://www.ua.ac.be Organization Type:Education
 
Organization name:OREBRO UNIVERSITY
Administrative contact Address
Name:Johan LUNDBORG (Mr) FAKULTETSGATAN 1

OEREBRO
SVERIGE

Region:
Tel:+46-19303418
Fax:+46-19303465
E-mail:Contact
URL:http://www.oru.se Organization Type:Education
 
Organization name:UPPSALA UNIVERSITET
Administrative contact Address
Name:Lena HELLSTRÖM-WESTAS (Dr) St Olofsgatan 10B
Box 256
UPPSALA
SVERIGE

Region:SVERIGE ÖSTRA MELLANSVERIGE Uppsala län
Tel:+46-186114877
Fax:+46-186115583
E-mail:Contact
URL:http://www.uu.se Organization Type:Education
 
Organization name:EUROPEAN PAEDIATRIC MEDICINE COMPANY
Administrative contact Address
Name:Jacques DE WAELE (Mr) Dreve Sainte-Anne 68B

BRUXELLES
BELGIQUE-BELGIË

Region:REG.BRUXELLES-CAP./BRUSSELS HFDST. GEW.
Tel:+32-495582000
Fax:+32-22702618
E-mail:Contact
URL:http://www.epmc-pharma.com Organization Type:
 
Organization name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Administrative contact Address
Name:Christophe MISSE (Mr) 3 Avenue Victoria

PARIS
FRANCE

Region:ÎLE DE FRANCE Ile de France Paris
Tel:+33-144841770
Fax:+33-144841788
E-mail:Contact
URL:http://www.aphp.fr Organization Type:Education,Other
 
Organization name:LUNDS UNIVERSITET
Administrative contact Address
Name:Vineta FELLMAN (Professor) Paradisgatan 5c
117
LUND
SVERIGE

Region:SVERIGE SYDSVERIGE Malmöhus län
Tel:+46-46178279
Fax:+46-46177051
E-mail:Contact
URL:http://www.lu.se Organization Type:Education
 
Organization name:ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Administrative contact Address
Name:Ronald VAN SCHAIK (Dr) 's Gravendijkwal 230
2040
ROTTERDAM
NEDERLAND

Region:WEST-NEDERLAND NOORD-HOLLAND Agglomeratie Haarlem
Tel:+31-104633119
Fax:+31-104367894
E-mail:Contact
URL:http://www.erasmusmc.nl Organization Type:Other
 
Organization name:FRIEDRICH-ALEXANDER UNIVERSITAET ERLANGEN-NUERNBERG
Administrative contact Address
Name:Ulrike HERRMANN (Ms.) Schlossplatz 4
3520
ERLANGEN
DEUTSCHLAND

Region:BAYERN MITTELFRANKEN Erlangen, Kreisfreie Stadt
Tel:+49-91318534043
Fax:+49-91318526239
E-mail:Contact
URL:http://www.uni-erlangen.de Organization Type:Education
 
Organization name:UNIVERSITE LIBRE DE BRUXELLES
Administrative contact Address
Name:Angélique GREINDL (Ms.) Avenue Franklin Roosevelt 50

BRUXELLES
BELGIQUE-BELGIË

Region:REG.BRUXELLES-CAP./BRUSSELS HFDST. GEW.
Tel:+32-26503240
Fax:+32-26502321
E-mail:Contact
URL:http://www.ulb.ac.be Organization Type:Education
 
Organization name:HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Administrative contact Address
Name:Merja TAKALA (Ms.) STENBACKINKATU 9
100
HELSINKI
SUOMI/FINLAND

Region:MANNER-SUOMI UUSIMAA
Tel:+358-947173023
Fax:+358-947175404
E-mail:Contact
URL:http://www.hus.fi Organization Type:
 

Record control number:89980




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