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Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-06-2014 | Award Amount: 2.99M | Year: 2015

Very preterm birth is a principal determinant of motor and cognitive impairment in later life. About 50 000 infants in the EU survive very preterm birth annually and are at much higher risk of cerebral palsy, visual and auditory deficits, impaired cognitive ability, psychiatric disorders and behavioural problems than infants born at term. However, the long term prognosis at initial discharge from hospital for each individual infant is unknown. Follow-up screening and prevention programmes aim to identify health problems early, enable interventions to improve outcome and to allow optimal management of health care. Despite the recognised importance of these programmes, little is known about their actual application and impact. These programmes consume significant resources because of the multidisciplinary staff required for clinical and developmental assessments and interventions, the coordination required to maintain contact with children after discharge and the time input from families. This project uses a unique resource the EPICE cohort of 6675 babies born before 32 weeks of gestational age and surviving to discharge home in 18 geographically diverse regions in 2011/2012 to assess the impact of these screening programmes on health, care and quality of life for very preterm infants and their families as well as on coverage, ability to meet needs, health equity and costs at the population-level. It will also generate new knowledge about assessment tools and methods. Four inter-related studies will be carried out in 11 EU countries by a multi-disciplinary consortium of clinicians (in obstetrics, paediatrics, and child development), researchers (in epidemiology, health services research and health economics) and a user organisation. Partners have the expertise to implement this project and the national and international renown to translate its result into better programmes and policies.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2013.5.2 | Award Amount: 5.89M | Year: 2013

CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous VPH projects and checks the applicability and effectiveness of available predictive modelling and simulation tools, validating them in interrelated clinical trials conducted in three European centres of excellence in cardiac treatment (from Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a result treatment becomes mandatory, but optimum timing and the best type of treatment still remain difficult to determine. With more than 50.000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at covering and comparing the complete spectrum of cardiovascular treatment, predicting the evolution of the disease and the immediate and mid-term outcome of treatment. Operational clustering is going to provide a seamless clinical solution that applies different modeling methods to realize the potential of personalised medicine taking into account user-friendliness as a key component of clinical usability. CARDIOPROOFs goal is to provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus accelerating the deployment of VPH methods in clinical environments, and bring to maturity holistic patient-specific computer-based predictive models and simulations.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2011.5.2 | Award Amount: 16.43M | Year: 2013

MD-Paedigree is a clinically-led VPH project that addresses both the first and the second actions of part B of Objective ICT-2011.5.2:\n1. it enhances existing disease models stemming from former EC-funded research (Health-e-Child and Sim-e-Child) and from industry and academia, by developing robust and reusable multi-scale models for more predictive, individualised, effective and safer healthcare in several disease areas;\n2. it builds on the eHealth platform already developed for Health-e-Child and Sim-e-Child to establish a worldwide advanced paediatric digital repository.\nIntegrating the point of care through state-of-the-art and fast response interfaces, MD-Paedigree services a broad range of off-the-shelf models and simulations to support physicians and clinical researchers in their daily work. MD-Paedigree vertically integrates data, information and knowledge of incoming patients, in participating hospitals from across Europe and the USA, and provides innovative tools to define new workflows of models towards personalised predictive medicine. Conceived of as a part of the VPH Infostructure described in the ARGOS, MD-Paedigree encompasses a set of services for storage, sharing, similarity search, outcome analysis, risk stratification, and personalised decision support in paediatrics within its innovative model-driven data and workflow-based digital repository. As a specific implementation of the VPH-Share project, MD-Paedigree fully interoperates with it. It has the ambition to be the dominant tool within its purview. MD-Paedigree integrates methodological approaches from the targeted specialties and consequently analyzes biomedical data derived from a multiplicity of heterogeneous sources (from clinical, genetic and metagenomic analysis, to MRI and US image analytics, to haemodynamics, to real-time processing of musculoskeletal parameters and fibres biomechanical data, and others), as well as specialised biomechanical and imaging VPH simulation models.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2013.2.2.1-4 | Award Amount: 16.45M | Year: 2013

DESIRE will focus on epileptogenic developmental disorders EDD, i.e. early onset epilepsies whose origin is closely related to developmental brain processes. A major cause of EDD are malformations of cortical development (MCD), either macroscopic or subtle. EDD are often manifested as epileptic encephalopathies (EE), i.e. conditions in which epileptic activity itself may contribute to severe cognitive and behavioral impairments. EDD are the most frequent drug-resistant pediatric epilepsies carrying a lifelong perspective of disability and reduced quality of life. Although EDD collectively represent a major medical and socio-economic burden, their molecular diagnosis, pathogenic mechanisms (PM) and rationale treatment are poorly understood. Specific objectives of DESIRE are to advance the state of the art with respect to: (1) the genetic and epigenetic causes and PM of EDD, particularly epileptogenic MCD, to elucidate molecular networks and disrupted protein complexes and search for common bases for these apparently heterogeneous disorders. (2) the diagnostic tools (biomarkers) and protocols through the study of a unique and well-characterized cohort of children to provide standardized diagnosis for patient stratification and research across Europe. (3) treatment of EDD using randomized, multidisciplinary clinical protocols and testing preclinical strategies in experimental models to also address novel preventative strategies. The workplan spans from clinical observation, to whole exome studies, cellular and animal models and basic research, identification of biomarkers and improvement of diagnostic methods, and back to the clinical trials and assessment of innovative, targeted treatment strategies. The consortium partners have an outstanding track record in genetics, basic neurophysiology, neuropathology and clinical research. Specialized expertise will be made available by the SMEs involved to develop novel diagnostic tools for tailored treatment approaches.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.4.2-1 | Award Amount: 7.38M | Year: 2013

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.

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