The CloSed Consortium comprises 12 European partners:
University Hospital Erlangen (UKER) is the academic research and teaching hospital of the Friedrich-Alexander University Erlangen-Nuremberg (FAU).
UKER is the coordinator of the CloSed project and thus responsible for the conduction of the project from the administrative and the scientific point of view. The Department of Paediatrics and Adolescent Medicine is leading these activities. In addition it is specifically involved in the clinical trial and recruitment of patients. Besides, the UKER Hospital Pharmacy is responsible for the development of the age-appropriate medicinal product (including formulation, manufacture, release and distribution). The Centre for Clinical studies contributes to the clinical study management, pharmacovigilance and data management of the clinical trial.
Ass Prof Dr Antje Neubert
University Hospital Erlangen
University College London (UCL) is one of the world’s top universities and is extremely active in EU research funding programs. Known as ‘London’s Global University’, UCL has 11 associated teaching hospitals, which includes Great Ormond Street Hospital for children (GOSH). The UCL Institute of Child Health (ICH), in partnership with GOSH, is the largest centre in Europe devoted to clinical and basic research and postgraduate teaching in children’s health.
In CloSed UCL is represented by two departments, the Centre for Paediatric Pharmacy Research (CPPR) at the School of Pharmacy (SoP) and the pharmacometrics group based at the Institute of Child Health (ICH).
UCL-SoP coordinates the paediatric formulation development, assures IMP is manufactured according to GMP and in a timely manner and makes sure that quality data are completely available for the PUMA application. UCL-ICH is in charge of perform the PK-PD modelling and the statistical analysis, which involves study design and input into protocol development and analysing and reporting the study results
Dr Catherine Tuleu
University College London
Therakind is a private European paediatric pharmaceutical company established in 2006 and dedicated to create, develop and improve paediatric medicines.
In CloSed Therakind oversees all regulatory activities relating to both the clinical trial and PUMA application and is responsible for the preparation and submission of the PUMA. Therakind is also responsible for the Monitoring and Quality Assurance.
Dr Susan Conroy
Erasmus Universitair Medisch Centrum Rotterdam (EMC) is, with its over 50 departments, the largest and most versatile of the eight university medical centres in the Netherlands. The paediatric ICU of the Erasmus MC-Sophia Children’s Hospital is one of the most research oriented paediatric intensive care units in Europe.
Within CloSed, EMC is responsible for the design and conduct of the RCT from the scientific perspective and for patient recruitment. EMC is involved in the overall scientific coordination of the project as well as in the development of a European Consensus Guideline for sedation in severely ill newborns and children. Furthermore, the Department of Biostatistics is involved in the statistical analysis of the trial.
Prof Dick Tibboel
Erasmus Universitair Medisch Centrum Rotterdam
Gianni Benzi Foundation (FGB) is a registered not-for-profit scientific research organisation founded in 2007. Its mission is to contribute to the advancement of pharmacological research in the fields of neuropathies, rare diseases, paediatric drugs, regulatory sciences and doping.
In the CloSed project FGB is responsible for the training and dissemination activities and contributes to regulatory activities and project management
Prof Adriana Ceci
Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus
Karolinska Institute (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.
Within CloSed KI is responsible for patient recruitment and participates in the PK-PD analyses.
Prof Per-Arne Lönnqvist
University of Tartu (UTARTU) is an academic institution with main focus on under- and postgraduate teaching and research from fundamental investigations to apply clinical and Health Services research. Testing Centre of University of Tartu (UTTC) is a unit within the Institute of Chemistry, which provides chemistry-related services and also some services related to physics.
UTARTU coordinates the medical-ethical issues in accordance with ICH-Guidelines, on Good Clinical Practice (GCP) and coordination of the ethical advisory board and is responsible for the development and validation of a method for sample preparation.
Ass Prof Dr Tuuli Metsvaht
University of Tartu
Charles University Prague (CUNI), is one of the world’s oldest universities and is dedicated to international co-operation with prestigious educational and research institutions. The Department of Paediatrics and Adolescent Medicine is part of the Charles University in Prague and is one of the largest paediatric clinics in Prague providing special care at all levels (resuscitation, intensive, basic, rehabilitation, clinical pharmacology) for all paediatric age groups.
CUNI is involved in patient recruitment for the RCT and actively participates in the development of European Guidelines for sedation in critically ill newborns and children.
Prof Jiri Zeman Charles
University in Prague
Vereniging Samenwerkende Ouder – en Patiëntenorganisaties (VSOP) is the Dutch national patient umbrella organisation for rare and genetic disorders and represents about 70 disease-specific patient and parent organisations in The Netherlands. VSOP is one of the founding members of EGAN an European network of patient organisations for both rare and common diseases (www.egan.eu and www.biomedinvo4all.com).
VSOP will act on behalf of EGAN, which voices and articulates a clear, patient focused perspective on genetic and medical biotechnological issues and their ethical, legal, psycho-social and cultural implications in the European political, scientific and industrial arena. VSOP also works together with several other European umbrella organisations like EPF, Eurordis and EFCNI (European Foundation for the Care of Newborn Infants), European disease specific organisations and individual expert parents / patients.
In CloSed, VSOP connects the clinical/scientific work of the project with the European patient perspective and is responsible for the set up and maintenance of a Patient Advisory Board (PAB). It advises on ethical and communication issues from a European patient perspective.
Dr Cor Oosterwijk
Vereniging Samenwerkende Ouder – en Patiëntenorganisaties
Bambino Gesù Paediatric Hospital & Scientific Institute (OPBG) is a significant point of reference for paediatrics at a national and international level and is now part of the network of the Italian healthcare system.
OPBG is involved in patient recruitment for the RCT and contributes to the development of Guidelines for sedation of severely ill newborns and children.
OPBG EU funding share: 107,311.75 €
In charge of the project for OPBG, Prof Paolo Rossi
Bambino Gesù Paediatric Hospital & Scientific Institute
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Civico, Di Cristina, Benfratelli (ARNAS-Civico) is based in Palermo. It includes two hospital districts, the first dedicated to care of the child, Hospital Di Cristina, and the second, the Civico Hospital, dedicated to both adults and newborns. The latter is the reference centre for management of high-risk pregnancies and newborns at high risk of morbidity and mortality in western Sicily. The Civico Hospital has 2,000 births annually, and its NICU/Neonatology Unit is a new recruitment site for neonatal patients in the CloSed study. The Unit has inborn and outborn admissions ranging around 500 patients/year and has conducted clinical studies on neonatal analgesia and Cerebral Near-Infrared Spectroscopy (NIRS) monitoring in preterm and term newborns with ischemic hypoxic encephalopathy in hypothermic treatment.
Dr S. Marcello Vitaliti
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Civico, Di Cristina, Benfratelli
The Hospital 12 de Octubre is a third-level public hospital (it provides health care from specialists after referral from primary care and secondary care), part of Madrid Regional Health Service (SERMAS). Three departments “Mother and Child” cover the full range of paediatric intensive care: the neonatal intensive care unit, the paediatric intensive care unit and the post-anaesthesia critical care unit. The Hospital is Baby Friendly certified and a NIDCAP centre. It has 1.400 beds, in two main divisions (the General Hospital, with 950 beds, and the Mother and Child Hospital with 450 beds), and 7000 employees overall.
Hospital 12 de Octubre is a recruiting site for the CloSed study and expects to contribute to the scientific discussions and development of guidelines for sedation of newborns, children and youth. Paediatric patients are admitted to one of three intensive care units (the neonatal intensive care unit, the paediatric intensive care unit and the post-anaesthesia care unit) that cover the full age range of CloSed participants.
Dr Javier De la Cruz
Hospital Universitario 12 de Octubre
European Society of Paediatric and Neonatal Intensive Care (ESPNIC) is a non-profit-making organisation dedicated to the care of critically ill children and newborns and represents more than 23 countries in Europe. Prof. Dick Tibboel is chair of the scientific committee of ESPNIC and thus assures an effective link between ESPNIC and the CloSed project.
ESPNIC is the ideal platform to provide European expertise into the project and to widely disseminate information on CloSed. As a third party in the project ESPNIC makes its resources available to the CloSed project.
Prof. Dick Tibboel