[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455039":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":28,"responsibleParty":193,"collaborators":196,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":10,"eligibilityCriteria":226,"healthyVolunteers":223,"sex":227,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":10,"studyType":233,"phases":10,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Neonates and Parents\u002FCaregivers",null,"Providers caring for newborns that meet eligibility criteria will approach parents to assess interest. The VIGOR study staff will remotely contact parents to complete consent for genomic sequencing (GS). We will also invite 1 additional primary caregiver (e.g. father, co-mother etc.) to participate even if that caregiver is not biologically related to the child.\n\nWe will administer surveys at baseline enrollment to assess sociodemographics, obstetrical history, family genetic history \\& mental health; within 1 week of disclosure of findings to assess satisfaction \\& mental health; \\& at 3 \\& 6 months to further assess mental health \\& newborn clinical outcomes. We will approach a subset of the families for qualitative interviews to assess satisfaction with VIGOR \\& receipt of GS results with their physician in more detail.",{"label":13,"type":10,"description":14,"interventionNames":10},"Clinicians","Following focus groups at each of the participating sites to assess the feasibility \\& needs of each site, the care teams will receive basic training in genomics and how to disclose GS results with VIGOR support. Study orientation will be completed as part of the training. Focus groups will be conducted within 1 year post implementation \\& again between year 4 \\& the completion of the study, to assess feasibility \\& appropriateness of VIGOR. We will administer brief surveys to the care providers before \\& after receipt of genomic education to assess their baseline knowledge \\& comfort with genomic medicine in newborns. Surveys will be repeated within a week of disclosure to families regarding feedback on the process \\& satisfaction with VIGOR. After approximately 3-5 disclosure events, study staff will approach the clinical care team members to participate in a qualitative interview to assess their perspectives in more depth.",[16],{"name":17,"affiliation":5,"role":18},"Timothy Yu, MD, PhD","PRINCIPAL_INVESTIGATOR",[20,24],{"name":17,"role":21,"phone":22,"phoneExt":10,"email":23},"CONTACT","617-919-7499","timothy.yu@childrens.harvard.edu",{"name":25,"role":21,"phone":26,"phoneExt":10,"email":27},"Vanessa J Young, MS, BA, RN","617-355-8330","vanessa.young@childrens.harvard.edu",[29,50,66,81,97,116,137,152,160,178],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"USA Children's and Women's Hospital","RECRUITING","Mobile","Alabama","36604","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-88.04305,30.69436,{"lat":41,"lon":40},[44,48],{"name":45,"role":21,"phone":46,"phoneExt":10,"email":47},"Ellen Dean, BSN, RN","251-415-1088","edean@health.southalabama.edu",{"name":49,"role":18,"phone":10,"phoneExt":10,"email":10},"Manimaran Ramani, MD",{"facility":51,"status":31,"city":52,"state":53,"zip":54,"country":35,"countryCode":36,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Holtz Children's Hospital at Jackson Memorial Medical Center","Miami","Florida","33136",{"type":38,"coordinates":56},[57,58],-80.19366,25.77427,{"lat":58,"lon":57},[61,65],{"name":62,"role":21,"phone":63,"phoneExt":10,"email":64},"Pankaj Agrawal, MD, MMSC","617-919-2357","pagrawal@miami.edu",{"name":62,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":67,"status":31,"city":68,"state":69,"zip":70,"country":35,"countryCode":36,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Boston Medical Center","Boston","Massachusetts","02118",{"type":38,"coordinates":72},[73,74],-71.05977,42.35843,{"lat":74,"lon":73},[77,80],{"name":78,"role":21,"phone":10,"phoneExt":10,"email":79},"Bharati Sinha, MD","Bharati.Sinha@bmc.org",{"name":78,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":82,"status":31,"city":83,"state":69,"zip":84,"country":35,"countryCode":36,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Baystate Medical Center","Springfield","01199",{"type":38,"coordinates":86},[87,88],-72.58981,42.10148,{"lat":88,"lon":87},[91,95],{"name":92,"role":21,"phone":93,"phoneExt":10,"email":94},"Robert Rothstein","413-794-2400","Robert.rothstein@baystatehealth.org",{"name":96,"role":18,"phone":10,"phoneExt":10,"email":10},"Robert Rothstein, MD",{"facility":98,"status":31,"city":99,"state":69,"zip":100,"country":35,"countryCode":36,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"UMass Memorial Hospital","Worcester","01605",{"type":38,"coordinates":102},[103,104],-71.80229,42.26259,{"lat":104,"lon":103},[107,111,115],{"name":108,"role":21,"phone":109,"phoneExt":10,"email":110},"Lawrence Rhein, MD, MPH","508-334-6206","lawrence.rhein@umassmemorial.org",{"name":112,"role":21,"phone":113,"phoneExt":10,"email":114},"Anjana Bhami Shenoy","508-334-6090","anjanabhami.shenoy@umassmed.edu",{"name":108,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":117,"status":31,"city":118,"state":119,"zip":120,"country":35,"countryCode":36,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Cooper University Hospital","Camden","New Jersey","08103",{"type":38,"coordinates":122},[123,124],-75.11962,39.92595,{"lat":124,"lon":123},[127,132,136],{"name":128,"role":21,"phone":129,"phoneExt":130,"email":131},"Vineet Bhandari, MD, DM","856-342-2000","1006156","Bhandari-vineet@cooperhealth.edu",{"name":133,"role":21,"phone":134,"phoneExt":10,"email":135},"Faye Shapiro, MS, LCGC","856-541-6213","shapiro-faye@cooperhealth.edu",{"name":128,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":138,"status":31,"city":139,"state":140,"zip":141,"country":35,"countryCode":36,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Driscoll Children's Hospital Rio Grande Valley","Edinburg","Texas","78539",{"type":38,"coordinates":143},[144,145],-98.16334,26.30174,{"lat":145,"lon":144},[148],{"name":149,"role":21,"phone":150,"phoneExt":10,"email":151},"Dynio Honrubia, MD","956-802-8855","dynio.honrubia@dchstx.org",{"facility":153,"status":31,"city":139,"state":140,"zip":141,"country":35,"countryCode":36,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"The Women's Hospital at Renaissance",{"type":38,"coordinates":155},[144,145],{"lat":145,"lon":144},[158,159],{"name":149,"role":21,"phone":150,"phoneExt":10,"email":10},{"name":149,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":161,"status":31,"city":162,"state":140,"zip":163,"country":35,"countryCode":36,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"The Hospitals of Providence","El Paso","79938",{"type":38,"coordinates":165},[166,167],-106.48693,31.75872,{"lat":167,"lon":166},[170,174,177],{"name":171,"role":21,"phone":172,"phoneExt":10,"email":173},"Dhruv Gupta, MD","313-896-8168","dhruv.gupta@pediatrix.com",{"name":175,"role":21,"phone":10,"phoneExt":10,"email":176},"Jenifer Gehlsen, MD","jenifer.gehlsen@pediatrix.com",{"name":171,"role":18,"phone":10,"phoneExt":10,"email":10},{"facility":179,"status":31,"city":180,"state":140,"zip":181,"country":35,"countryCode":36,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"University of Texas Medical Branch","Galveston","77555",{"type":38,"coordinates":183},[184,185],-94.7977,29.30135,{"lat":185,"lon":184},[188,192],{"name":189,"role":21,"phone":190,"phoneExt":10,"email":191},"Maria E Franco-Fuenmayor, MD","409-772-2815","mefranco@utmb.edu",{"name":189,"role":18,"phone":10,"phoneExt":10,"email":10},{"type":18,"investigatorFullName":194,"investigatorTitle":195,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Timothy Yu","Associate Professor of Pediatrics",[197,198,199,201,203,206,208,211,213,215,217,219],{"name":67,"class":6},{"name":82,"class":6},{"name":200,"class":6},"UMass Memorial Health",{"name":202,"class":6},"The Cooper Health System",{"name":204,"class":205},"National Human Genome Research Institute (NHGRI)","NIH",{"name":207,"class":6},"DHR Health Institute for Research and Development",{"name":209,"class":210},"The Hospitals of Providence East Campus","UNKNOWN",{"name":212,"class":210},"The Hospitals of Providence Memorial Campus",{"name":214,"class":6},"Jackson Health System",{"name":216,"class":6},"University of Texas",{"name":218,"class":6},"Driscoll Children's Hospital",{"name":220,"class":6},"University of South Alabama","100455039","vigor-virtual-genome-center-for-infant-health-100455039",false,"NCT05205356","VIGOR: Virtual Genome Center for Infant Health","Inclusion Criteria:\n\n* Newborns presenting with probable genetic conditions inpatient on the NICU. These may include (but is not limited to) those with unexplained hypotonia, seizures, metabolic disorders, disorders of sex development, interstitial lung disease, immunodeficiency or multiple congenital anomalies.\n* Babies must have at least one biologic parent available for consent and participation.\n* The criteria for inclusion are 100% phenotype based and do not include any demographic parameters.\n\nExclusion Criteria:\n\n* Presence of a likely nongenetic explanation for the phenotype (e.g., perinatal asphyxia explained by uterine rupture or placental pathology;\n* Clinical features pathognomonic for a recognizable chromosomal abnormality, such as trisomy 21;\n* Associations already known to have low genetic diagnostic yield, including VATER\u002FVACTERL association and OEIS complex;\n* Infants who die before enrollment;\n* Known family history of genetic disease that is plausibly the cause of the infant's illness; - Those with a prenatal genetic diagnosis.","ALL","0 Days","99 Years",{"count":231,"type":232},750,"ESTIMATED","OBSERVATIONAL","This study will provide rigorous evaluation of implementing a virtual genome center into community clinical settings without highly specialized resources, thereby offering generalizable insights as to how best to implement genomic medicine at scale and for other age groups. This intervention has great potential to address disparities in genomic medicine among low-income and underrepresented minority (URM) populations and will enhance capacity for providers and health systems to utilize highly specialized genomic techniques in their communities.\n\nThe goal of this study is to achieve equitable access to state-of-the-art genomic medical care to sick newborns in community centers that predominately care for low-income and racial\u002Fethnic minority populations through the creation of a virtual genome center (VIGOR). VIGOR will provide a venue for physician and family education, genomic expert consultation, reanalysis of unsolved sequencing data, and access to cutting edge therapeutic innovation, thereby facilitating institutionalization of genomic best practices in community settings, and not just highly specialized referral centers.",[236,237,238],"Genetics Disease","Genetics\u002FBirth Defects","Genetic Predisposition to Disease",[240],"Genetics","2026-01-30",{"date":243,"type":244},"2026-02-03","ACTUAL",{"date":246,"type":244},"2022-03-22",{"date":248,"type":232},"2027-03-01",{"name":5,"class":6},10]