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Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit

CloSed is a 5-year project funded under the Seventh Framework Programme (FP7) with an international Consortium comprising 10 European partners and coordinated by Assoc. Prof. Antje Neubert, University Hospital of Erlangen.

The project aims to conduct a multicentre clinical trial of clonidine in children until the age of 18. Indeed, despite its widespread use in Pediatric Intensive Care Units (PICU), this drug still lacks authorisation for paediatric use. A parenteral age-appropriate formulation of clonidine for sedation in PICU will be developed and tested in order to obtain a Pediatric Use Marketing Authorisation (PUMA).

Latest News

24Jul

Study protocol publication in BMJ Open Journal

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On 21st June 2017 the study protocol was published online by Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost... Read More →
30Jun

Site Initiation Visit at Karolinska Institutet children’s hospital (Stockholm)

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On June 14th2017, the Site Initiation Visit (SIV) was held at the new building of Karolinska Institutet children’s hospital (KI)... Read More →

European Research in Paediatrics

EU Paediatric Regulation includes provisions for funding of research into off-patent medicines leading to PUMAs. In this context, the EU launched several calls under FP7 to develop age-appropriate formulations and/or delivery systems of off-patent drugs used in paediatrics, and the CloSed project has been selected for funding.

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CloSed is an EU-funded project

CloSed is an EU-funded project

This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement n.602453

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