National Observatory of Unexpected Infant Deaths FRESH-PEF74055-en Léa Ferrand National Observatory of Unexpected Infant Deaths Registre OMIN FRESH-PEF74055-en 74055 FRESH-PEF74055 Christèle GRAS LE GUEN CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES Epidemiology France Portal (PEF) CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES FONDATION AXA LES RIRES D'ANNA NAITRE ET VIVRE SA VIE SANTE PUBLIQUE FRANCE null Léa;FERRAND CNIL Unexpected infant death Sudden infant death syndrome National registry Paediatrics Public, environmental and occupational health Sudden infant death syndrome Socio-demographic and economic determinants Socio-demographic and economic determinants: Employment Socio-demographic and economic determinants: Education level Socio-demographic and economic determinants: Age Environmental determinants Environmental determinants: Climate Environmental determinants: Other Behavioral determinants Behavioral determinants: Eating habits Biological determinants Biological determinants: Genetic predisposition Biological determinants: Sex Other Epidemiological surveillance Obtain accurate and comprehensive epidemiological data Identification of new risk factors for SIDS Development of medical research in the field of SIDS Sudden infant death (SIDS) is defined as “a sudden death in a child under 1 year of age that could not have been predicted by in the child’s known medical history could have predicted it,” whereas “sudden infant death (SID)” is the death of an infant under 1 year of age that cannot be explained by the clinical history or by postmortem investigations; in France, the Haute Autorité de Santé (HAS) has set the upper age limit at 2 years. In 2007, the HAS published recommendations for the management of SIDS intended for the 30 “SIDS” reference centers; it described the diagnostic procedures to be implemented, which, following an investigation by the French Institute for Public Health Surveillance in 2009, were found to be followed very inconsistently. Since then, no further data has been published in France, and this condition has been the subject of very little research, even though it still affects 300 to 400 infants per year, 50 to 70% of whom remain unexplained deaths. It is thus the leading cause of death among infants aged 1 month to 1 year in France. The objective of this project is to establish a French National Observatory on Minor Injuries (OMIN) with three main goals: 1) to obtain accurate epidemiological data on this condition, 2) to identify its determinants, and 3) to describe its management in French referral centers. In the medium term, these figures will enable the development of clear and up-to-date prevention messages for the general public and healthcare professionals. Based on these figures, hypotheses for clinical and basic research can also be formulated and serve as the rationale for studies drawing on the diversity of data collected through the registry. This registry includes all children under the age of 2 admitted for MIN at French referral centers. A wide range of clinical, biological, radiological, and pathological data is collected in an online observation log. Biological samples for a biobank are also collected following signed parental consent. All of this data will be analyzed under the responsibility of the OMIN Scientific Committee to ensure the best possible scientific use of the information. Environmental conditions at the time of death are systematically reported (sleeping position, bedding, smoking, etc.). Access to these patients’ DNA will also enable genetic research to test the potential predisposing role of certain genes. The consequences of pre- or postnatal exposure to certain nutrients or chemical, biological, or pharmaceutical toxins can be precisely characterized by cross-referencing data recorded by the observatory with that of the National Health Data System (SNDS). Whether in France or internationally, there is an urgent need to collect epidemiological, clinical, environmental, biological, and health-related data on NCDs. We are proposing here an original and unique project in this field. This registry, and the analysis of the data it contains, constitutes an essential starting point for the development and evaluation of future, more effective information and prevention campaigns in the field of NCDs. By simultaneously providing a wide variety of research data, this registry will also facilitate cutting-edge scientific research based on evidence-based hypotheses, leading to the discovery of original findings in the field of NCDs. France Auvergne Rhône-Alpes Bourgogne Franche-Comté Bretagne Centre-Val de Loire Grand Est Guadeloupe Guyane Hauts-de-France Ile-de-France La Réunion Martinique Normandie Nouvelle-Aquitaine Occitanie Pays de la Loire Provence - Alpes - Côte d'Azur Individus Patients population Female Male Infant, Newborn (birth to 28 days) Infant (28 days to 2 years) Infant aged 0 to 24 months who died of sudden infant death syndrome and was treated in France by a MIN reference center Clinical data Biological data Socio-demographic data Environmental / exposure data Economic data Participant-reported health data Automatic consistency checks and monitoring of 100% of files Cause of death Prospective longitudinal Daily Complete enumeration (including consecutive recruitment) Through organizations (health services or institutions schools businesses etc.) [1000-10000[ individuals Converting or copying information into a structured record Interview with the participant (including clinical) Observation (clinical or behavioural) Observational Study Observational Study Morbidity registry 2441 au 05/05/2026 Ongoing study Nantes University Hospital Restricted access https://www.omin.fr/charte-dutilisation-des-donnees-processus-demande/ Léa;FERRAND OMIN Study Group and CRB, if applicable Yes The OMIN data and sample access charter is available on request from bp-coordination-omin@chu-nantes.fr Requests for access to data are made by means of a project form, which must be sent to omin@chu-nantes.fr for appraisal by members of the Scientific Advisory Board. The opinion is given within 1 month. Free admission