[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623045":3},{"organization":4,"outcomesModule":7,"designInfo":15,"detailedDescription":21,"studyPopulation":11,"armGroups":22,"interventions":28,"overallOfficials":33,"centralContacts":40,"locations":50,"responsibleParty":103,"collaborators":105,"id":114,"slug":11,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":11,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":121,"enrollmentInfo":122,"targetDuration":11,"studyType":125,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Institute of Health Information and Statistics of the Czech Republic","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of premature infants with identified pathology at 5 years (overall, by detected pathology)",null,"During study participation (up to 3 days)",{"measure":14,"description":11,"timeFrame":12},"Proportion of premature infants referred to a specialized center (overall, by detected pathology)",{"allocation":16,"interventionModel":17,"interventionModelDescription":11,"primaryPurpose":18,"observationalModel":11,"timePerspective":11,"maskingInfo":19},"NA","SINGLE_GROUP","SCREENING",{"masking":20,"maskingDescription":11,"whoMasked":11},"NONE","The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.\n\nThe main goal of the project is establishing a methodology for the long-term monitoring of premature infants (in the area of developmental anomalies) and their evaluation at the age of 5 years.\n\nThe main objective of this activity is to validate this screening process, which will benefit 210 patients in 2 perinatal and 2 intermediate centers. The child will undergo a comprehensive pediatric examination, including basic vision, speech, and psychomotoric assessments (MABC-2 and IDS-P). If any concerns are identified, the child will be referred to an appropriate specialist. The timeliness of this check-up has significant positive impact on both the patient and their family.\n\nThe project is supported by the European Social Fund (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02\u002F00\u002F22\\_005\u002F0002020.\n\nThe study has been reviewed and approved by multiple local ethical committees. The listed IRB represents the lead national ethical committee overseeing the trial.",[23],{"label":24,"type":25,"description":11,"interventionNames":26},"5 year old children born prematurely","OTHER",[27],"Other: Pediatric check-up",[29],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Pediatric check-up","Eligible children are invited to undergo a comprehensive pediatric evaluation, including vision screening (Plusoptix) and speech and language tests (TEPO - sentence comprehension, TEPRO - vocabulary production). Subsequently, children are referred for psychological (IDS-P), motor (MABC-2), and pulmonary (spirometry) assessments. If any deviations are identified, the child is referred to appropriate specialists (e.g., rehabilitation physician, speech therapist, psychiatrist, ophthalmologist).",[24],[34,38],{"name":35,"affiliation":36,"role":37},"Daniela Marková, M.D.","General Hospital University in Prague","STUDY_DIRECTOR",{"name":39,"affiliation":36,"role":37},"Richard Plavka, prof.",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Daniela Dokoupilová, MSc","CONTACT","+420725441408","daniela.dokoupilova@uzis.cz",{"name":47,"role":43,"phone":48,"phoneExt":11,"email":49},"Lucie Mandelová, Ph.D.","+420770190828","lucie.mandelova@uzis.cz",[51,67,78,90],{"facility":52,"status":53,"city":54,"state":55,"zip":11,"country":56,"countryCode":11,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"České Budějovice Hospital","RECRUITING","České Budějovice","Czech Republic","Czechia",{"type":58,"coordinates":59},"Point",[60,61],14.47434,48.97447,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":11,"phoneExt":11,"email":66},"Kateřina Matějová, MD","katerina.matejova@nemcb.cz",{"facility":68,"status":53,"city":69,"state":55,"zip":11,"country":56,"countryCode":11,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Hospital Havlíčkův Brod","Havlíčkův Brod",{"type":58,"coordinates":71},[72,73],15.57937,49.6069,{"lat":73,"lon":72},[76],{"name":77,"role":43,"phone":11,"phoneExt":11,"email":11},"Magdalena Chvílová Weberová, weberova@onhb.cz",{"facility":79,"status":53,"city":80,"state":55,"zip":11,"country":56,"countryCode":11,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"County Hospital Liberec","Liberec",{"type":58,"coordinates":82},[83,84],15.05619,50.76711,{"lat":84,"lon":83},[87],{"name":88,"role":43,"phone":11,"phoneExt":11,"email":89},"Evženie Knězů, MD","evzenie.knezu@nemlib.cz",{"facility":91,"status":53,"city":92,"state":55,"zip":11,"country":56,"countryCode":11,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"General University Hospital","Prague",{"type":58,"coordinates":94},[95,96],14.42076,50.08804,{"lat":96,"lon":95},[99],{"name":100,"role":43,"phone":101,"phoneExt":11,"email":102},"Daniela Marková, MD","+420 602 644 481","daniela.markova@vfn.cz",{"type":104,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[106,107,109,112],{"name":52,"class":25},{"name":108,"class":25},"General University Hospital, Prague",{"name":110,"class":111},"Hospital Havlickuv Brod","UNKNOWN",{"name":113,"class":111},"County Hospital Liberec, Liberec","100623045",false,"NCT07391527","Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age","Early Detection and Prevention of Health Complications in Premature Infants - Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age","Inclusion Criteria:\n\n* Signed consent for participation in the project and consent for the processing of personal data.\n* Children born before 37 weeks of gestation, aged 5 years, growing up in a Czech-speaking environment.\n* To ensure valid linkage of all data sources, the children must have been born to parents with Czech citizenship.\n\nExclusion Criteria:\n\n* Unsigned consent for participation in the project and consent for the processing of personal data.\n* Severe psychomotor retardation .\n* Severe congenital malformations.","ALL","5 Years",{"count":123,"type":124},210,"ESTIMATED","INTERVENTIONAL",[16],"The project is a national, prospective, multicenter, interventional pilot project focused on the follow up of 5 year old children that were born prematurely.\n\nThe primary aim of the project is to prepare, test, and develop a proposal for a national methodology for the care of children born prematurely. This will minimize the negative impacts on the overall development of the child and the family of the prematurely born children.",[129],"5 Year Old Children Born Prematurely",[131,132,133,55],"follow up of premature infants","early detection","developmental abnormality","2026-02-02",{"date":136,"type":137},"2026-02-06","ACTUAL",{"date":139,"type":137},"2025-09-23",{"date":141,"type":124},"2027-02-28",{"name":5,"class":6},4]