Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit
Public support
Provider
Ministry of Education, Youth and Sports
Programme
—
Call for proposals
7E13034-2013
Main participants
Univerzita Karlova / 1. lékařská fakulta
Contest type
RP - Co-financing of EC programme
Contract ID
MSMT-42111/2013
Alternative language
Project name in Czech
Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit
Annotation in Czech
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 project 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 been approved by the EMA in February 2013 and is reflected in the work plan of CloSed. The project will increase the availability of paediatric medicines, foster the conduct of clinical trials in children and establish international paediatric research collaborations
Scientific branches
R&D category
AP - Applied research
CEP classification - main branch
FG - Paediatrics
CEP - secondary branch
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CEP - another secondary branch
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OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)
30209 - Paediatrics
Completed project evaluation
Provider evaluation
U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)
Project results evaluation
Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.
Solution timeline
Realization period - beginning
Jan 1, 2014
Realization period - end
Nov 30, 2018
Project status
U - Finished project
Latest support payment
Feb 14, 2018
Data delivery to CEP
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data delivery code
CEP19-MSM-7E-U/01:1
Data delivery date
Jun 18, 2019
Finance
Total approved costs
1,400 thou. CZK
Public financial support
1,400 thou. CZK
Other public sources
0 thou. CZK
Non public and foreign sources
0 thou. CZK