CloSed is expected to have the following concrete outcomes:
An intravenous clonidine formulation with appropriate strengths for different age groups will be developed to allow an accurate dosing with a minimum risk for dosing and administration errors.
A randomised, double-blind, active comparator controlled clinical trial in 300 neonates and children will be conducted to provide evidence-based data on the safety and efficacy, including dosing recommendations of clonidine to be used for sedation on PICUs.
The project will help to better understand long-term outcomes following the use of sedative agents (clonidine/midazolam) in the neonatal age group, to improve the assessment of benefits and risks of the treatment by the healthcare professionals.
Data will be used to apply for a Paediatric Use Marketing Authorisation (PUMA) for the specifically age-appropriate IV clonidine product, so that a licensed product, specific for use in sedation in PICUs and NICUs, will be available.
International guidelines, implementing the results of the study, will be prepared via a consensus approach to cope with the lack of European guidelines and the low level of evidence supporting the currently available treatment options.
Results will be also disseminated to a wide range of health-care professionals, expecting a significant improvement of clinical practice.
It has been estimated that potentially around 120,000/year of critically ill newborns and children will benefit from CloSed, thanks to the availability of a licensed clonidine product for sedation in PICUs and the establishment of consensus guidelines for sedation.
CloSed will extend the experience in conducting clinical research in the vulnerable paediatric population, contributing to establish international paediatric research cooperation and encourage the partners to participate in clinical trials beyond CloSed.
CloSed will increase the scientific knowledge regarding the use of clonidine in PICUs by bringing academic expertise together and using modern clinical trial methodologies (i.e. PK-PD modelling) to define the best possible study design, compliant with all ethical aspects in paediatrics.
In addition, the new clonidine formulation developed in CloSed will be marketed, increasing the availability of paediatric medicines. Thus, CloSed has an ideal synergism of scientific and market knowledge.