[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593381":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Sharp HealthCare","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Consented, Enrolled","EXPERIMENTAL","All participants who meet inclusion and exclusion criteria and whose parent has provided written informed consent.",[13],"Diagnostic Test: Targeted genomic sequencing",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Targeted genomic sequencing","Single 0.5 mL venous or capillary blood sample.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Anup Katheria, MD","CONTACT","858-939-4170","Anup.Katheria@sharp.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Sharp Mary Birch Hospital for Women and Newborns","San Diego","California","92123","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-117.16472,32.71571,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Jason B Sauberan, PharmD","858-939-7424","jason.sauberan@sharp.com",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Anup Katheria, M.D.","Director, Neonatal Research Institute, Sharp Mary Birch Hospital for Women and Newborns",[51],{"name":52,"class":53},"MedySapiens","UNKNOWN","100593381","rapid-diagnostics-for-genetic-disorders-in-neonates-100593381",false,"NCT07005700","Rapid Diagnostics for Genetic Disorders in Neonates","Development of Rapid Diagnostics for Genetic Disorders in Neonates Using a Novel Targeted Genomic DNA Sequencing Analysis Panel.","Inclusion Criteria: neonates of any gestational age.\n\n* Abnormality in routine neonatal screening test.\n* Unexplained neonatal hypotonia or neonate-onset seizures.\n* Unexplained and abnormal biochemical laboratory findings.\n* Skeletal dysplasia or joint problems.\n\nExclusion Criteria:\n\n* Parental refusal of consent to participate.\n* Provider refusal.\n* Any condition that, in the opinion of the investigator, would interfere with interpretation of study results.","ALL","1 Day","6 Months",{"count":65,"type":66},100,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this study is to test a prototype genomic blood analysis for identifying rare diseases in infants hospitalized in the neonatal intensive care unit (NICU).\n\nThe main question it aims to answer is: Does the prototype accurately identify genetic variation(s) associated with an infant's health condition?\n\nResearchers will compare the prototype's gene identification to traditional genome sequencing methods of gene identification.\n\nParticipants will be asked to provide a very small (one-tenth of a teaspoon) sample of blood, one-time.",[72],"Acid Base Disorder","NOT_YET_RECRUITING","2025-05-27",{"date":76,"type":77},"2025-06-05","ACTUAL",{"date":79,"type":66},"2025-06-30",{"date":81,"type":66},"2027-05",{"name":5,"class":6},1]