The Paediatric European Network for Treatment of AIDS (PENTA, www.pentatrials.org) was established in 1991 as collaboration between paediatric HIV centres in Europe. The aim was to undertake independent clinical trials to address questions about antiretroviral therapy (ART) in HIV infected children where answers cannot be extrapolated from trials in adults. By Nov 2008, more than 80 clinical centres in 16 countries and nearly 1500 children have been enrolled in 15 major CTs. Within the 6th FP, the coordination of the European Collaborative Study (ECS), one of the largest cohorts of children born to HIV positive mothers, has been integrated with PENTA, thus forming a single centralised European network for research on paediatric HIV. Activities are now including not just clinical trials, but cohort studies collaboration, pregnancy studies (including phase 1 trials in pregnant women) and training/ educational programs. More than 50 papers in peer-reviewed journal have been published by Nov 2008. By the end of 2008 PENTA is coordinating 3 EU-funded projects (PENTA/ECS, PENTA LABNET and ACTIVATE) and is partner of 3 additional large integrated adult and children projects (NEAT, CHAIN, EuroCOORD). In addition PENTA receives funding from the Medical Research Council (MRC), the INSERM/ANRS, from the US-NIH and, for specific projects from pharmaceutical companies. Given the varied activities undertaken by PENTA and financed from different sources, in 2004 the need has arisen to bring formally together all PENTA related activities. PENTA Foundation was set up in May 2004 as PENTA co-ordinating centre and to support activities aimed at carrying out research on HIV and related diseases. The Foundation is a promoter/sponsor of clinical trials according to the GCP guidelines and new relevant European Directives, a centre for the collection, study, research and dissemination of information on HIV related issues, and co-ordinate training programmes for health providers. The founder members have been working together and running the PENTA network since 1991 and represent key institutions for PENTA activities such as Dipartimento di Pediatria of Padova, ANRS/INSERM SC10 HIV Trial Unit, Paris, MRC-CTU, London, Necker Hospital, Paris and University of Padova. The inception of the Foundation stems from the co-operation and results achieved through the network activities of PENTA to date, which have been funded by the European Commission since 1993, with considerable additional input, particularly on the technical side of trial management by the MRC-CTU, INSERM, the Italian Institute of Health and research grants from the NIH and pharmaceutical companies. Since 2008 PENTA is also formally present within the EMEA Paediatric Committee (PDCO) as scientific and research organisation. PENTA Foundation has the ideal infrastructure and expertise to provide the general framework for the management of NeoMero across different European countries. This framework should also serve as a model for future studies on other drugs for Paediatric infectious disease. PENTA Foundation is directly linked to the Department of Pediatrics of the University of Padova, a large referral academic hospital with about 300 beds. A large NICU has about 600 admissions per year and a great experience in epidemiological and clinical research in neonates.