Copy
CloSed Project
Improving sedation of children in critical care

 

Welcome to the third Newsletter of CloSed, a 5-year project funded by the European Union, aimed to improve patients’ treatment in the intensive care setting by studying clonidine.

CloSed will develop a new formulation of clonidine specifically designed for children and conduct a clinical trial in patients under the age of 18 with the aim to generate safety and efficacy data on clonidine in children, to support Paediatric Use Marketing Authorisation (PUMA) application and to develop guidelines for sedation of critically ill newborns and children in the Paediatric Intensive Care Unit (PICU). Throughout the project, the health outcome of children will be of utmost priority and all research activities will be conducted in accordance with European ethical requirements for studies involving the paediatric population.
 


 

 

Project Consortium


The project Consortium comprises 10 European partners: one not-for-profit organisation, five clinical centres, one SME, two universities and one patient organisation, all focused on developing appropriate medicines for children.

Read more

Clinical Study Protocol finalisation and submission in the Netherlands 


Following the finalisation of the Clinical Study Protocol, the Consortium is now close to enroll its first patients in the CloSed study.
The submission of the study relevant documents (e.g. clinical study protocol, patient information sheets, investigators brochure) to the Competent Authority and Ethics Committee has been started in the Netherlands for Erasmus University Medical Center (EMC, Rotterdam, NL).

Read more

CloSed study on ClinicalTrials.gov database


Following the inclusion of the CloSed clinical study on the European Clinical Trials Database EudraCT (European Drug Regulatory Authorities Clinical Trials), the European publicly available electronic database, a further step forward in the visibility and transparency of the CloSed project is represented by the recent registration of the study in ClinicalTrials.gov

Read more

Launch of the website on Comfort Assessment

 

One of the main activities of the CloSed study is the training of medical staff in order to provide the knowledge to obtain the outcome measures defined in the Clinical Study Protocol.
The scoring systems which will be used in the CloSed study are: COMFORT behaviour scale (COMFORT-B scale), Numeric Rating Scale (NRS) and Nurse Interpretation of Sedation Score (NISS).
In this respect, Erasmus Universitair Medisch Centrum Rotterdam (EMC) has developed appropriate training packages using modern technologies including online training, videos and training sessions in order to provide a standardised training for the study staff involved in patient recruitment.
In order to provide further help to healthcare professionals to use these instruments to assess pain, sedation, withdrawal syndrome and paediatric delirium, EMC also has recently launched a website (available at the following address: www.comfortassessment.nl) ...

 
Read More

The “Response Letter to Hünseler et al” recently published on the Pediatric Critical Care Medicine Journal


On January 2015, Yucheng Sheng and Joseph Standing (University College London, United Kingdom) have published on behalf of the CloSed Consortium, a Response Letter to Hünseler and colleagues. The letter, entitled “Pharmacokinetic Reason for Negative Results of Clonidine Sedation in Long-Term-Ventilated Neonates and Infants”, was published on the journal Pediatric Critical Care Medicine.

Read More

What's new

CloSed at Nextwork Forum in Bucharest


On May 16th, 2015, the CloSed project was presented in Bucharest (Romania) at the second edition of the European Projects Forum “Nextwork” 2015, aimed at networking and developing international relations with the various players of the EU grant-funded projects in order to share best practices.
CloSed has been presented in the “Project- Best practice presentations” session and a dedicated page on the project has been published on the Nextwork Forum official website (viewable at the following link)


Partners: Focus On


Recruiting Center


With its over 50 departments contributing to its three core tasks (patient care, research and education), Erasmus University Medical Center Rotterdam (EMC) is the largest and most versatile of the eight university medical centres in the Netherlands.
Erasmus MC-Sophia Children’s Hospital is a 250 beds children’s hospital located next to the adult EMC and the Medical Faculty. The Pediatric Intensive Care Unit (PICU) is one of the most research-oriented paediatric intensive care units in Europe. It includes 4 units with a total of 28 beds and 1700 admissions yearly. 

Partner's website

Recruiting Center


Karolinska Institutet (KI) is one of the world´s leading medical universities and currently represents more than 40% of all academic medical research in Sweden. It has a close collaboration with the Astrid Lindgren Children’s Hospital, which belongs to the Karolinska University Hospital.
The Department of Paediatric Anaesthesia and Intensive Care at the Astrid Lindgren Children's Hospital provides services in five sections: Anaesthesia including recovery, Intensive Care, Long-Term Intensive Care Unit (ICU), Karolinska ECMO Centre (ExtraCorporeal Membrane Oxygenation), and the Pain Unit. 

Partner's website



CloSed Principal Investigator:
interview to Prof. Dr. Dick Tibboel (EMC)

The importance of the CloSed study and its benefits and potentials for the European clinical research as well as for patients and families has been the object of an interview to Prof. Dr. Dick Tibboel, Head of ICU, Director of Research Sophia Children's Hospital, Erasmus MC, University Medical Center Rotterdam and Principal Investigator of the CloSed study.
“The importance of the CloSed study”, as explained by Prof. Tibboel, “lies in the huge potential to help reaching evidence for sedation in critically ill children”.

Read more
Copyright © 2014 Closed Project, All rights reserved.
Facebook
Facebook
Website
Website

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