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No Pain during infancy by adapting off-patent medicines

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 ”child friendly” formulation adapted for use in neonates will be developed by the SME partner in the NeoOpioid project. The results will be disseminated by scientific and popular articles, the web, videos and special pain courses for physicians and nurses etc. The NeoOpioid project will lead to a considerable improvement of the strategy to alleviate newborn pain.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmacokinetics

Call for proposal

FP7-HEALTH-2007-B
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

KAROLINSKA INSTITUTET
Address
Nobels Vag 5
17177 Stockholm
Sweden
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 044 845
Administrative Contact
Thomas Walstam (Mr.)

Participants (12)

UPPSALA UNIVERSITET

Participation ended

Sweden
EU contribution
€ 11 151
Address
Von Kraemers Alle 4
751 05 Uppsala
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Lena Hellström-Westas (Dr.)
MAX IV Laboratory, Lund University
Sweden
EU contribution
€ 100 000
Address
Paradisgatan 5C
22100 Lund
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Vineta Fellman (Prof.)
OREBRO UNIVERSITY
Sweden
EU contribution
€ 79 998
Address
Fakultetsgatan 1
70182 Orebro
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johan Lundborg (Mr.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 130 080
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ronald Van Schaik (Dr.)
EUROPEAN PAEDIATRIC MEDICINE COMPANY
Belgium
EU contribution
€ 350 000
Address
Dreve Sainte-anne 68B
1020 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jacques De Waele (Mr.)
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
EU contribution
€ 80 000
Address
Stenbackinkatu 9
00029 Helsinki
Activity type
Research Organisations
Administrative Contact
Merja Takala (Ms.)
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 30 000
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Angela Noble (Ms.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 281 650
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Christophe Misse (Mr.)
UNIVERSITEIT ANTWERPEN

Participation ended

Belgium
Address
Prinsstraat 13
2000 Antwerpen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Anne Adams (Ms.)
FRIEDRICH-ALEXANDER-UNIVERSITAET ERLANGEN-NUERNBERG
Germany
EU contribution
€ 91 400
Address
Schlossplatz 4
91054 Erlangen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ulrike Herrmann (Ms.)
UNIVERSITY OF LEICESTER
United Kingdom
EU contribution
€ 50 040
Address
University Road
LE1 7RH Leicester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Marie Singer (Ms.)
UNIVERSITE LIBRE DE BRUXELLES
Belgium
EU contribution
€ 50 000
Address
Avenue Franklin Roosevelt 50
1050 Bruxelles
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Angélique Greindl (Ms.)