Clonidine for Sedation of Paediatric Patients in the Paediatric Intensive Care Unit

akronüüm: CloSed
algus: 2013-12-01
lõpp: 2018-11-30
 
programm: FP7 - Euroopa Liidu 7. raamprogramm
alaprogramm: HEALTH - Tervis
instrument: CP-FP - Väikese- ja keskmisemahulised koostööprojektid
projektikonkurss: FP7-HEALTH-2013-INNOVATION-1
projekti number: 602453
kestus kuudes: 60
partnerite arv: 10
 
lühikokkuvõte: The majority of critically ill children admitted to Paediatric Intensive Care Units (PICU) will require sedation and analgesia which is commonly achieved with a combination of an benzodiazepine and an opioid. However, these agents have a significant side-effect profile, including tolerance, withdrawal and respiratory/circulatory depression. Clonidine is commonly used for sedation in PICU and recommended by guidelines in various countries although there is a lack of evidence regarding it safety and efficacy in this setting. The need for safety and efficacy data as well as an age appropriate formulation for clonidine has been realised and clonidine is included in the EMA “Revised Priority List for Studies into Off-patent Medicinal Products”. Thus this proposal addresses an important paediatric therapeutic need. It is designed to fullfill the requirements for most ethical research in the paediatric population considering risk minimisation for patients, avoiding unnecessary studies and make use of already available data as outlined in the Paediatric Regulation (EC) No 1901/2006. The objectives of this proposal are a) to develop an age appropriate formulation of clonidine suitable for sedation of children in PICU b) to conduct a randomised, phase III, double-blind, active-controlled parallel group clinical trial of clonidine vs midazolam in patients from birth to 18 years to establish the efficacy and safety, including long-term outcomes and dose-dependent effects of clonidine and c) to establish an European consensus guideline for sedion of critically ill children. The ultimate goal is to use these data and to apply for a PUMA. On this basis a Paediatric Investigation Plan (PIP) has already been submitted to the EMA. Favourable Day 90 feedback has been received and incorporated accordingly. This project will increase the availability of paediatric medicines, foster the conduct of clinical trials in children and establish international paediatric research collaborations.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator UNIVERSITAETSKLINIKUM ERLANGEN DE Antje Neubert http://www.uk-erlangen.de
2 partner UNIVERSITY COLLEGE LONDON UK Catherine Tuleu http://www.ucl.ac.uk
3 partner Therakind Ltd UK Susan Conroy
4 partner ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL Dick Tibboel http://www.erasmusmc.nl
5 partner FONDAZIONE PER LA RICERCA FARMACOLOGICA GIANNI BENZI ONLUS IT Viviana Giannuzzi http://www.benzifoundation.org
6 partner KAROLINSKA INSTITUTET SE Per-Arne Lönnqvist http://www.ki.se
7 partner Tartu Ülikool EE Tuuli Metsvaht http://www.ut.ee
8 partner UNIVERZITA KARLOVA V PRAZE CZ Pavla Pokorna http://www.cuni.cz
9 partner EUROPEAN GENETIC ALLIANCES' NETWORK BE Cor Oosterwijk
10 partner OSPEDALE PEDIATRICO BAMBINO GESU IT Paolo Rossi http://www.ospedalebambinogesu.it