[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648078":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":148,"collaborators":151,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":177,"sex":183,"minAge":184,"maxAge":185,"enrollmentInfo":186,"targetDuration":25,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":203,"whyStopped":25,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"Università degli Studi di Brescia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Participants receive a caregiver-mediated, home-based digital intervention delivered through the VIPPSTAR platform, parallel to standard clinical care, within a framework that promotes and strengthens the parent-child\u002Fcaregiver-child relationship. The intervention includes personalized developmental activities, audiovisual materials, weekly online supervision, and continuous communication with clinicians. It includes participants enrolled in both the main RCT cohort and the exploratory pilot cohort.",[13],"Behavioral: VIPPSTAR Digital Early Intervention",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard Care Arm","Participants receive standard clinical monitoring and care according to local clinical practice without access to the VIPPSTAR intervention platform.",[18],"Other: Standard Clinical Care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","VIPPSTAR Digital Early Intervention","A caregiver-mediated digital intervention aimed at promoting visual and neurodevelopmental outcomes in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child\u002Fcaregiver-child relationship. The intervention includes individualized activities integrated into daily family routines and supported through remote supervision and e-learning content.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Clinical Care","Routine clinical care provided according to local healthcare protocols, including follow-up visits and additional evaluations if clinically indicated.Standard intervention protocols according to local healthcare services are allowed.",[15],[31],{"name":32,"affiliation":33,"role":34},"Jessica Galli, Prof","Unit of Child Neurology and Psychiatry, ASST Spedali Civili of Brescia, Italy - Department of clinical and experimental sciences, University of Brescia, Brescia, Italy","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Jessica Galli, Professor","CONTACT","00390303995724","jessica.galli@unibs.it",[42,62,88,107,130],{"facility":43,"status":25,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Katholieke Universiteit Leuven","Leuven","3000","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],4.70093,50.87959,{"lat":52,"lon":51},[55,59],{"name":56,"role":38,"phone":57,"phoneExt":25,"email":58},"Els Ortibus, Prof","0032 16 34 39 91","els.ortibus@uzleuven.be",{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Lauren Billestraet, Dr","SUB_INVESTIGATOR",{"facility":63,"status":25,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"ASST Spedali Civili di Brescia","Brescia","BS","25123","Italy","IT",{"type":49,"coordinates":70},[71,72],10.21472,45.53558,{"lat":72,"lon":71},[75,78,80,82,84,86],{"name":76,"role":38,"phone":39,"phoneExt":25,"email":77},"Serena Micheletti, Dr","serena.micheletti@unibs.it",{"name":79,"role":38,"phone":39,"phoneExt":25,"email":25},"Lucrezia Maria Visconti, Dr",{"name":81,"role":61,"phone":25,"phoneExt":25,"email":25},"Nicole D'Adda, Dr",{"name":83,"role":61,"phone":25,"phoneExt":25,"email":25},"Anna Alessandrini, Dr",{"name":85,"role":61,"phone":25,"phoneExt":25,"email":25},"Laura Dusi, Dr",{"name":87,"role":61,"phone":25,"phoneExt":25,"email":25},"Elisa Maria Fazzi, Prof",{"facility":89,"status":25,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"University of Brescia",{"type":49,"coordinates":91},[71,72],{"lat":72,"lon":71},[94,95,98,99,100,101,103,105],{"name":32,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":96,"role":38,"phone":25,"phoneExt":39,"email":97},"Erika Loi, Dr","erika.loi@unibs.it",{"name":96,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":85,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":79,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":102,"role":61,"phone":25,"phoneExt":25,"email":25},"Stefano Calza, Prof",{"name":104,"role":61,"phone":25,"phoneExt":25,"email":25},"Elisa Fazzi, Prof",{"name":106,"role":61,"phone":25,"phoneExt":25,"email":25},"Melissa Marras, Dr",{"facility":108,"status":25,"city":109,"state":65,"zip":25,"country":67,"countryCode":68,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Department of Brain and Behavioral Sciences University of Pavia - Child Neurology and Psychiatry Unit IRCCS Mondino Foundation","Pavia",{"type":49,"coordinates":111},[112,113],9.15917,45.19205,{"lat":113,"lon":112},[116,120,122,124,126,128],{"name":117,"role":38,"phone":118,"phoneExt":25,"email":119},"Simona Orcesi, Prof","0039 0382.380280","simona.orcesi@unipv.it",{"name":121,"role":61,"phone":25,"phoneExt":25,"email":25},"Sabrina Signorini, Dr",{"name":123,"role":61,"phone":25,"phoneExt":25,"email":25},"Cecilia Naboni, Dr",{"name":125,"role":61,"phone":25,"phoneExt":25,"email":25},"Antonella Luparia, Dr",{"name":127,"role":61,"phone":25,"phoneExt":25,"email":25},"Sonia Trussardi, Dr",{"name":129,"role":61,"phone":25,"phoneExt":25,"email":25},"Benedetta Brafa, Dr",{"facility":131,"status":25,"city":132,"state":25,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Centrul Republican de Reabilitare pentru Copii","Chisinau","MD-2019","Moldova","MD",{"type":49,"coordinates":137},[138,139],28.85938,47.00902,{"lat":139,"lon":138},[142,146],{"name":143,"role":38,"phone":144,"phoneExt":25,"email":145},"Ecaterina Gîncotă, Dr","+373 686 84279","kbufteac@gmail.com",{"name":147,"role":61,"phone":25,"phoneExt":25,"email":25},"Amalia Dolinschii, Dr",{"type":34,"investigatorFullName":149,"investigatorTitle":150,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jessica Galli","Principal Investigator",[152,155,157,159,161,163,165,167,169,171,173],{"name":153,"class":154},"ASST Spedali Civili of Brescia, Brescia, Italy","UNKNOWN",{"name":156,"class":154},"Department of Development and Regeneration, KU Leuven, Leuven, Belgium",{"name":158,"class":154},"Centrul Republican de Reabilitare pentru Copii, Moldova",{"name":160,"class":154},"Vestibular and oculomotor laboratory, Department of Neuroscience, Erasmus MC, Rotterdam, The Netherlands",{"name":162,"class":154},"National Center for Rare Diseases, Istituto Superiore di Sanità, Rome, Italy",{"name":164,"class":154},"LIGHT Center, Brescia, Italy",{"name":166,"class":154},"EODYNE SYSTEMS SL, Barcelona, Spain",{"name":168,"class":154},"Department of Psychology and Cognitive Science, University of Trento, Rovereto, Italy",{"name":170,"class":154},"Department of Brain and Behavioral Sciences University of Pavia, Pavia, Italy",{"name":172,"class":154},"Child Neurology and Psychiatry Unit IRCCS Mondino Foundation, Pavia, Italy",{"name":174,"class":154},"VIPPSTAR Consortium","100648078","vippstar-g1-digital-early-intervention-for-visual-impairment-100648078",false,"NCT07717671","VIPPSTAR-G1 Digital Early Intervention for Visual Impairment","VIPPSTAR-G1: A Multicenter Randomized Controlled Trial Evaluating a Caregiver-mediated Digital Intervention to Promote Visual Function and Neurodevelopment in Infants at Risk of\u002FWith Visual Impairment","VIPPSTAR-G1","Inclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment\n\n* Gestational age ≤32 weeks OR full-term\u002Fnewborns\\>32 weeks of age with neonatal distress (Apgar ≤5 at 10 minutes)\n* NAVEG score ≥3\n* At least one neurological or neuroimaging abnormality:\n\n  * 3 abnormal signs at ATNAT neurological examination OR Abnormal cranial ultrasound findings OR Abnormal MRI findings\n\nExclusion Criteria: Study Sample 1 - Infants at Risk of Visual Impairment\n\n* Epileptic encephalopathy\n* Parents unable to understand local language\n\nInclusion Criteria: Study Sample 2 - Infants\u002FToddlers With Visual Impairment\n\n* Age ≤42 months\n* Diagnosis of peripheral or cerebral visual impairment\n* Moderate or severe visual impairment documented by standardized visual acuity testing Exclusion Criteria: Study Sample 2 - Infants\u002FToddlers With Visual Impairment\n* Age \\>42 months\n* Refractory epilepsy or epileptic encephalopathy\n* Participation in another interventional study within previous 12 months\n* Parents unable to understand local language","ALL","1 Day","42 Months",{"count":187,"type":188},150,"ESTIMATED","INTERVENTIONAL",[191],"NA","Visual impairment in infancy is associated with significant risks for neurodevelopmental impairment. Early intervention based on enriched visual and multisensory experiences may promote neuroplasticity and improve developmental outcomes, but implementation of intensive interventions in routine clinical practice remains challenging. The VIPPSTAR-G1 study evaluates a caregiver-mediated digital intervention delivered through a dedicated platform designed to support visual and neurodevelopmental functions in infants at risk of or with visual impairment, within a framework that promotes and strengthens the parent-child\u002Fcaregiver-child relationship.\n\nThis multicenter, multinational, single-blind randomized controlled trial will enroll 102 newborns at risk of visual impairment and an additional exploratory pilot subgroup of 48 infants and toddlers with established visual impairment. Participants will be randomized to receive either the VIPPSTAR digital intervention plus standard care or standard care alone. Outcomes include visual acuity, smooth pursuit, additional neuro-ophthalmological functions, neurodevelopmental measures, adaptive functioning, language development, parental stress, quality of life, and feasibility of the digital intervention.",[194,195,196,197],"Visual Impairment","Cerebral Visual Impairment","Neurodevelopmental Disorders","Prematurity",[199,200,201,202],"visual impairment","early intervention","digital health","prematurity","NOT_YET_RECRUITING","2026-07-16",{"date":206,"type":207},"2026-07-21","ACTUAL",{"date":209,"type":188},"2026-07-01",{"date":211,"type":188},"2028-06-30",{"name":5,"class":6},5]