[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538324":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":56,"locations":66,"responsibleParty":83,"collaborators":85,"id":88,"slug":10,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":10,"enrollmentInfo":97,"targetDuration":10,"studyType":100,"phases":10,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"groupe 1",null,"60 parents of children screened for PKU. Each of them will be assessed using a socio-psychological questionnaire (7 days after the announcement) and the revised event impact scale (7 days, 4 and a half months).",[13,14],"Behavioral: socio-psychological questionnaire","Behavioral: revised event impact scale (IER-S)",{"label":16,"type":10,"description":17,"interventionNames":18},"groupe 2","25 parents from group 1. This smaller sample of 25 parents will be subjected to non-directive interviews (1 month after the announcement) and to the Stern interview (4 and a half months after the announcement).",[13,14,19,20],"Other: Non directive interview","Other: Stern interview",{"label":22,"type":10,"description":23,"interventionNames":24},"groupe 3","15 doctors : interview",[25],"Other: semi-directive interview",{"label":27,"type":10,"description":28,"interventionNames":29},"groupe 4","5 midwifes : short interview",[25],[31,36,40,44,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"BEHAVIORAL","socio-psychological questionnaire","ton collecte socio-demographic variable",[9,16],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"revised event impact scale (IER-S)","22 items assessed on a scale of frequency from 0 (not at all) to 4 (extremely)",[9,16],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Non directive interview","composed of a very broad opening sentence to encourage the parents' discourse",[16],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"Stern interview","54 questions to investigate the impact of the announcement and the parenthood construction",[16],{"type":6,"name":49,"description":50,"armGroupLabels":51,"otherNames":10},"semi-directive interview","to propose ideas for improving and harmonizing practices",[22,27],[53],{"name":54,"affiliation":5,"role":55},"Céline BENSIMON","STUDY_CHAIR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":61},"Pascale DELONLAY, MD, PhD","CONTACT","+33 1 44 49 48 52","pascale.delonlya@aphp.fr",{"name":63,"role":59,"phone":64,"phoneExt":10,"email":65},"Aminata TRAORE","+33 1 42 19 27 34","aminata.traore6@aphp.fr",[67],{"facility":68,"status":69,"city":70,"state":10,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hôpital Necker Enfants Malades","RECRUITING","Paris","75015","France","FR",{"type":75,"coordinates":76},"Point",[77,78],2.3488,48.85341,{"lat":78,"lon":77},[81],{"name":58,"role":59,"phone":60,"phoneExt":10,"email":82},"pascale.delonlay@aphp.fr",{"type":84,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[86],{"name":87,"class":6},"URC-CIC Paris Descartes Necker Cochin","100538324",false,"NCT06289348","Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience.","Announcement of Rare Metabolic Diseases as Part of Systematic New-born Screening: the Experience of Phenylketonuria.","ANNPHE","Inclusion Criteria:\n\n* Parent or doctor of a child screened for PKU, born during the inclusion phase of the study\n* Family's first exposure to PKU: the PKU child must be either the eldest or the first sibling to be diagnosed with PKU following neonatal screening\n\nExclusion Criteria:\n\n* Failure to master the French language.\n* Child screened is neither the eldest nor the first sibling to be screened.\n* Refusal by the parents.\n* Any other reason which, in the investigator's judgement, would impair the participants' ability to follow the study protocol, or the interpretation of interview data (e.g. the participating parent has a history of serious psychiatric pathology, one of the parents died at the child's birth, Couples in which one of the members suffers from a known decompensated psychiatric pathology at the time of recruitment. Couples where one of the members is under legal protection or a security measure, etc …).","ALL","18 Years",{"count":98,"type":99},80,"ESTIMATED","OBSERVATIONAL","The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis.",[103],"Phenylketonuria",[105,106,107,108,109,110,111,112,113,114],"presymptomatic announcement","systematic neonatal screening","rare diseases","genetic disease","phenylketonuria","care relationship","psychological trauma","psychological impact","parent-child bonding","parenthood","2026-06-22",{"date":117,"type":118},"2026-06-24","ACTUAL",{"date":120,"type":118},"2024-05-07",{"date":122,"type":99},"2027-05-20",{"name":5,"class":6},1]