The French prospective multisite registry on sudden unexpected infant death (OMIN): rationale and study protocol. Issue 4 (17th April 2018)

• Record Type: Journal Article
• Authors: Levieux, Karine; Patural, Hugues; Harrewijn, Inge; Briand Huchet, Elisabeth; de Visme, Sophie; Gallot, Géraldine; Chalumeau, Martin; Gras Le Guen, Christèle; Hanf, Matthieu
• Other Names: author non-byline.; Garcia-Meric Patricia author non-byline.; Fayol Laurence author non-byline.; Pontual Loic De author non-byline.; Galerne Aurélien author non-byline.; Teychene-Coutet Anne-Marie author non-byline.; Netter Jean-Claude author non-byline.; Sibille Gaël author non-byline.; Maiz Fakhreddine author non-byline.; Englender Mariana author non-byline.; Broca Alain De author non-byline.; Rachieru-Sourisseau Petronela author non-byline.; Guillermet Christine author non-byline.; Pauls-Barsanti Julia author non-byline.; Le-Bot Christiane author non-byline.; Trentesau Anne-Sophie author non-byline.; Sebbouh Djamel author non-byline.; Perez-Martin Stéphanie author non-byline.; Maegd Muriel author non-byline.; Michard-Lenoir Anne-Pascale author non-byline.; Tahir Abdelilah author non-byline.; Kugener Béatrice author non-byline.; Muanza Blandine author non-byline.; Pidoux Odile author non-byline.; Dorion Anne Borsa author non-byline.; Afanetti Mickael author non-byline.; Tisseron Barbara author non-byline.; Rancurel Anne author non-byline.; Leguay Lolita author non-byline.; Robin Caroline author non-byline.; Lebeau Marie author non-byline.; Digeon Béatrice author non-byline.; Vrignaud Bénédicte author non-byline.; Farges Céline author non-byline.; Lecruit François author non-byline.; Dagorne Michel author non-byline.; Alessandri Jean-Luc author non-byline.; Samperi Sylvain author non-byline.; Balu Laurent author non-byline.; Mory Olivier author non-byline.; Breining Audrey author non-byline.; Duthoit Gilles author non-byline.; Daussac Elisabeth author non-byline.; Plee Yasmine author non-byline.; Chantepie Alain author non-byline.; Bouillo Myriam author non-byline.;
• Is Part Of: BMJ open. Volume 8:Issue 4(2018)
• Publication Date: 2018-04-17
• Subjects: sudden unexpected infant death -- sudden infant death -- France -- public health -- Observatoire National Des Morts Inattendues Du Nourrisson (OMIN) -- registry; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-020883
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Even after 'back-to-sleep' campaigns, sudden unexpected infant death (SUID) continues to be the leading cause of death for infants 1 month to 1 year old in developed countries, with devastating social, psychological and legal implications for families. To sustainably tackle this problem and decrease the number of SUIDs, a French SUID registry was initiated in 2015 to (1) inform prevention with standardised data, (2) understand the mechanisms leading to SUID and the contribution of the already known or newly suggested risk factors and (3) gather a multidisciplinary group of experts to coordinate and develop innovative and urgent research in the SUID area. Methods and analysis: This observational multisite prospective observatory includes all cases of sudden unexpected deaths in children younger than 2 years occurring in the French territory covered by the 35 participating French referral centres. From these cases, various data concerning sociodemographic conditions, death scene, personal and family medical history, parental behaviours, sleep environment, clinical examinations, biological and imagery investigations and autopsy are systematically collected. These data will be complemented as of 2018 with a biobank of diverse biological samples (blood, hair, urine, faeces and cerebrospinal fluid), with other administrative health-related data (health claim reimbursements and hospital admissions) and socioenvironmental data. Insights from exploratory descriptive statistics and thematic analysis will be combined for the design of targeted strategies to effectively reduce preventable infant deaths. Ethics and dissemination: The French sudden unexpected infant death registry (Observatoire National des Morts Inattendues du Nourrisson registry;OMIN) was approved in 2015 by the French Data Protection Authority in clinical research (Commission Nationale de l'Informatique et des Libertés: number 915273) and by an independent ethics committee (Groupe Nantais d'Ethique dans le Domaine de la Santé: number 2015-01-27). Results will be discussed with associations of families affected by SUID, caregivers, funders of the registry, medical societies and researchers and will be submitted to international peer-reviewed journals and presented at international conferences.