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No Pain during infancy by adapting off-patent medicines

Project information

Grant agreement ID: 223767

Status

Closed project

  • Start date

    1 October 2008

  • End date

    30 September 2013

Funded under:

FP7-HEALTH

  • Overall budget:

    € 2 881 489,14

  • EU contribution

    € 2 299 164

Coordinated by:

KAROLINSKA INSTITUTET

Sweden

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.
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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

Sweden

EU Contribution

€ 11 151

LUNDS UNIVERSITET

Sweden

EU Contribution

€ 100 000

OREBRO UNIVERSITY

Sweden

EU Contribution

€ 79 998

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 130 080

EUROPEAN PAEDIATRIC MEDICINE COMPANY

Belgium

EU Contribution

€ 350 000

HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ

Finland

EU Contribution

€ 80 000

THE UNIVERSITY OF EDINBURGH

United Kingdom

EU Contribution

€ 30 000

ASSISTANCE PUBLIQUE HOPITAUX DE PARIS

France

EU Contribution

€ 281 650

UNIVERSITEIT ANTWERPEN

Belgium

FRIEDRICH-ALEXANDER-UNIVERSITAET ERLANGEN NUERNBERG

Germany

EU Contribution

€ 91 400

UNIVERSITY OF LEICESTER

United Kingdom

EU Contribution

€ 50 040

UNIVERSITE LIBRE DE BRUXELLES

Belgium

EU Contribution

€ 50 000

Project information

Grant agreement ID: 223767

Status

Closed project

  • Start date

    1 October 2008

  • End date

    30 September 2013

Funded under:

FP7-HEALTH

  • Overall budget:

    € 2 881 489,14

  • EU contribution

    € 2 299 164

Coordinated by:

KAROLINSKA INSTITUTET

Sweden

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