Objective The aim of TAIN is to develop a neonatal formulation of hydrocortisone, a drug included in the EMA priority list that needs specific evaluation in the age range 0 – 2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as replacement therapy for the treatment of congenital and acquired adrenal insufficiency as well playing an important therapeutic role in oncology in infants, specifically brain tumours and leukaemia’s. TAIN involves European leaders in neonatology, paediatric pharmacology, methodology and SMEs that will establish links with ethical bodies and regulatory authorities. The programme will perform in silico experiments and evaluate formulations for neonates. The phase 3 clinical trial comparing the neonatal hydrocortisone versus current (unlicensed) therapy will be optimized using age-appropriate state-of-the-art methods adapted to neonates (including in silico experiments and pharmacokinetics) to validate the components of a Paediatric Investigation Plan. It will be performed by neonatologists trained in paediatric pharmacology and clinical research in line with guidelines on Good Clinical Practice. All the ethical issues will be considered, including pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form will be submitted to patient and parents’ associations for approval. TAIN will include short term safety studies and Phase 3 clinical studies in neonates and infants. Results will be reported in order to allow a PUMA application to be submitted and to improve neonatal and infant care. Therefore, TAIN will validate the appropriate use of hydrocortisone in neonates and infants which will be of direct benefit to children, their families and health professionals. TAIN will strengthen paediatric drug evaluation across Europe and build up a network of units with experience in clinical research that will be used for additional drug evaluation in neonates. Fields of science medical and health sciencesbasic medicinepharmacology and pharmacypharmacokineticsmedical and health sciencesclinical medicinepaediatricsmedical and health sciencesclinical medicineoncologyleukemia Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2011.4.2-1 - Investigator-driven clinical trials on off-patent medicines for children Call for proposal FP7-HEALTH-2011-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator THE UNIVERSITY OF SHEFFIELD Address Firth court western bank S10 2TN Sheffield United Kingdom See on map Region Yorkshire and the Humber South Yorkshire Sheffield Activity type Higher or Secondary Education Establishments Administrative Contact Finance Reseach Links Contact the organisation Opens in new window Website Opens in new window EU contribution No data Participants (7) Sort alphabetically Sort by EU Contribution Expand all Collapse all CERTARA UK LIMITED United Kingdom EU contribution € 164 077,20 Address One london wall 6th floor EC2Y 5EB London See on map Region London Inner London — West Camden and City of London Administrative Contact Martell Rebecca (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data CHARITE - UNIVERSITAETSMEDIZIN BERLIN Germany EU contribution € 769 696,80 Address Chariteplatz 1 10117 Berlin See on map Region Berlin Berlin Berlin Activity type Higher or Secondary Education Establishments Administrative Contact Eveline Fraessdorf (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data ADD ADVANCED DRUG DELIVERY TECHNOLOGIES AG Switzerland EU contribution € 180 000,00 Address Kagenstrasse 17 4153 Reinach See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Frederic Gerber (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data GLATT GMBH Germany EU contribution € 426 320,00 Address Werner-glatt-strasse 1 79589 Binzen See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Norbert Poellinger (Dr.) Links Contact the organisation Opens in new window Other funding No data DIURNAL LIMITED United Kingdom EU contribution € 1 659 845,20 Address Newport road - eastgate house - 8th floor 35-43 CF24 0AB Cardiff See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Ross Mcmaster (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data GENETIC ALLIANCE UK LTD United Kingdom EU contribution € 75 614,40 Address Unit 4d leroy house , essex road 436 N1 3QP London See on map Region London Inner London — East Haringey and Islington Activity type Other Administrative Contact Buddug Cope (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data THE UNIVERSITY OF BIRMINGHAM United Kingdom EU contribution € 178 936,80 Address Edgbaston B15 2TT Birmingham See on map Region West Midlands (England) West Midlands Birmingham Activity type Higher or Secondary Education Establishments Administrative Contact May Chung (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Other funding No data
