10 years Congenital survey in France
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1 10 years Congenital survey in France Sophie Alain, Elodie Loum, Marianne Leruez-Ville,Tiffany Lamblot, Sebastien Hantz National Reference center for cytomegaloviruses CMV Public Health and Policy Conference in Austin, Texas September th 2016.
2 CMV : The French paradox A major public health concern An unrecognized pathology The first cause of viral congenital disabilities The second cause for congenital hearing loss in France Limited therapeutic possibilities Current antivirals are toxic HIVIG effciacy remains controversial Vaccines and new antiviral approaches are in development (leruez et al. 2016) Sreening is «not recommended» since 2004 Hygien counselling was recommended but in fact not implemented =-Lack of women awareness of - risk and prevention, - diagnostic or therapeutic means available for infected newborns => Non organized «wild» screening Non prepared practitioners Heterogenous and stressful speech Increased risk for medical abortion => No screening at birth Newborns medical management is heterogeneous In the absence of guidelines
3 French teams involved in congenital CMV provide informations to their health authorities The reservoirs have been studied at the national level in 80 randomly selected day care centers : prevalence of CMV shedding is 40,88% (CrechMV, NCT , CNR CMV data) The highest viral loads are observed between 6 month and 18 months => Guidelines for day care providers to prevent infection of pregnant nurses : > 2 y.o. babies. CMV awareness was proven insufficient: Among midwives and obstetricians 30% were perfectly aware of CMV transmission and only 9% gave all the good responses (Cordier et al., 2012) In 1770 parents from the CrechMV study : Only 41,8 % of the mothers have heard about CMV in France In pregnant women less than 60% are aware (Cordier et al., 2012) Hygien counselling efficacy was shown since 2009 (Piccone et al.,2008, Vauloup-Fellous et al., 2009)
4 The congenital-cmv burden is underestimated Impact of congenital CMV on hearing loss has been retrospectively evaluated from Guthrie cards : CMV is the 2nd cause of congenital hearing loss : 8% in a 100 children cohort and 15.4% (8/52) in the subpopulation of children with profound bilateral hearing loss (Avettant-Fenoël, 2013). First Incidence data came from a 3 month national prospective survey nov 2004-jan 2005 from prenatal diagnosis centers : 0,35% When adjusted : 277 cases per year among which 46 were symptomatic leading to 30 medical abortions Underestimation of mild cases or secondary sequelae High rate of abortion (awareness?)
5 A first attempt to increase awareness in 2017 Flyers for parents (on the CNR website : cnr-cytomegalovirus.fr) and pregnant women with simple explanations on the prevention CENTRE NATIONAL DE REFERENCE DES CYTOMEGALOVIRUS Pourquoi le cytomégalovirus? Contacts : Pr Sophie ALAIN : ; sophie.alain@chu limoges.fr Dr Sébastien HANTZ : Le cytomégalovirus est un virus de la famille des virus herpès, responsable d infections le plus souvent inapparentes chez les jeunes enfants et les adultes jeunes. Ce virus persiste toute la vie après la première infection, et peut se réactiver, en général de façon silencieuse ; sebastien.hantz@chu limoges.fr Dans nos régions, une personne sur deux environ est infectée. Le virus circule de manière naturelle dans la population, surtout chez les jeunes enfants. cnr cytomegalovirus.fr Centre de Biologie et de Recherche en Santé CHU de LIMOGES 2, avenue Martin Luther King LIMOGES Tél :
6 CMV national survey since 2006 Case definition: congenital infection diagnosed by either amniotic fluid PCR or culture during pregnancy or viruria at birth. Classification of cases: cases were classified on the basis of symptoms detected either by sonographic examination or at birth. Severe: neurologic abnormalities, Mild: extra-neurologic symptoms, Asymptomatic: absence of sonographic or clinical symptoms, Not documented
7 Case declaration North France Prenatal diagnosis centers South France And overseas Virology laboratories Additional information query National Reference Center Additional information query Obstetricians Midwifes Paediatricians Data Base
8 Evolution of the number of cases declared by center 817 cases were declared since 2006, with a median of 87 (+/-24) declared cases per year In : 79 (+/-21) In : 81 (+/-26) total total
9 Evolution of case declaration since severe; 23% not documented; 35% mild; 17% asymptomatic; 25% Cases (n=447) Cases (n=356) not documented 27% severe, 20% not documented, 43% severe, 25% mild, 18% asymptoma c 30% asymptoma c 18% mild 17,5%
10 Repartition and characteristics of the 817 cases on the French territory ( ): DOM-TOM
11 Data from the 116 cases declared in 2015 Cases 2015 n=116, 75% severe not available; 22% Mother status Asymptomatic; 23% Primary infection; 40% symptoms; 55% not documented; 57% Secondary infection; 2% others; 3% neonatal death; 3% RCIU; 11% death in utero; 5% mental disabilities; 12% medical abortion; 28% neurological abnormality; 3% hearing loss; 35% 65 symptomatic cases with available data
12 Newborns treatment 2015 new born treatment of the 116 declared cases Treatment (valganciclovir); 2% No antiviral treatment; 9% Unborn; 12% Not documented; 78% Few data available to date on the use of newborn treatment by valganciclovir
13 Unmet needs Better coverage Heterogeneity of declarations : No cases or very few from the overseas territories Better documentation of cases Symptomatic cases are quite welldeclared but many cases are still not documented Asymptomatic cases or mother s infection without transmission are not declared Declaration is boring and time consuming Collection of biological samples associated to the case is still heterogeneous
14 How can we improve this survey? Constitute a unique electronic national data base easy to fill, by both obstatricians, midwives, biologists and paediatricians Improve exhaustivity Enlarge the declaration to CMV infections in pregnancy and lateonset congenital infection asymptomatic at birth To : Identify the real burden of CMV in the population Measure the impact of recommendations or vaccination when available Document newborns follow-up in the era of VGCV treatment Facilitate collaborative studies Enlargement to other countries is feasible, (for ex Europe in the continuum of Euro CMV for CCMV survey in population)
15 Specifications : Easy-to fill declaration for all practitioners Several entries for cases (gynecologist virologist paediatrician) Find duplicates Specific modules for the pregnancy and the newborn follow-up Adaptative modules of declaration (add modules for specific studies) Possibility of an imagery data base linked to the cases (RMN, ultrasound) Easy collection of data and compatibility with other data bases (extract data on specific topics) Autorisation from the French Commission Informatique et Liberté for both inquiry and biological collection => Potential for collaborative studies
16 First grant from the French ministry and our hospital 0,5 Assitant ingenieer Validated by French CNIL for 10 years with parental or mother consent for data and sample collection
17 Home page Nouvelle déclaration Rechercher une déclaration Suivi enfant Statistiques
18
19
20 Data base organization 1 declaration is one mother and one or more chidren Anonymous 0..1 Déclaratio n (Q) 0..1 Déclaration (P) (Q) = Questionnaire (P) = Page Mère (P) Avoid duplicates 0..* 0..1 Mother Clinics(P) 0..1 Mother Biology(P) 0..* Spécialist(s) (Q) 1declaration is from one or more specialists with login and password Fœtus / child (Q) 0..1 Fœtus biology (P) 0..1 Fœtus clinic (P) 0..1 Child Clinics(P) 0..1 Child Biology(P) 0..* Child follow-up(q)
21 Conclusions data identifed a burden of of 87 (+/-24) declared cases per year, among which at least 17% mild, and 25% severe, and thus could benefit from antiviral treatment This data base is mostly limited to cases symptomatic at birth and should be enlarged to asymptomatics and late-onset congenital disease The new electronic data base should increase the number of declarations The multiple entries (mother-baby) will facilitate exhaustive data collection, and burden evaluation With a specific follow-up of infected newborns This base has a potential for implementation in various countries to get information at the European level in the continuity of the EUROCMV Inquiry
22 Acknowledgements Pr WD Rawlinson All the virologists paediatricians, obstetricians, midwives My colleagues from the Reference center particularly Elodie Loum for her large participation in data collection and electronic data base preparation The EuroCMV team for their first attempt towards a European data base Mother and Child Hospital Limoges, France
Mrs Kate Johnston, Mr Phil Lindsey, Mrs Charlotte Wilson Dr Marieke Emonts, Mrs Ailsa Pickering. Newcastle upon Tyne Hospitals NHS Foundation Trust
'Testing for congenital cytomegalovirus (CMV) in babies identified with permanent childhood hearing impairment (PCHI) through the newborn hearing screening programme (NHSP) Mrs Kate Johnston, Mr Phil Lindsey,
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