CloSed (Clonidine for Sedation of Paediatric Patients in the Intensive Care unit) is a 5-year project funded under the Seventh Framework Programme (FP7) with an international Consortium comprising 10 European partners and coordinated by the University Hospital Erlangen.
The project aims to study clonidine, which is currently used off-label as sedative in paediatric intensive care units (PICU) and to conduct a multicentre clinical trial in children until the age of 18. Indeed, children in critical care, admitted to the intensive care unit and in need of sedation, are often treated with drugs that are not specifically approved for them. Thus, age-appropriate formulations and data on efficacy and safety are required for this drug.
CloSed project is expected to fill this gap, since it is aimed to develop and test a parenteral age-appropriate formulation of clonidine, specifically for the treatment of neonate, paediatric and adolescent patients. Once it will be demonstrated its efficacy and safety, the project results will be used to obtain a Paediatric Use Marketing Authorisation (PUMA).