[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577355":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":66,"collaborators":19,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":19,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-blinded, open label experimental arm","EXPERIMENTAL","The experimental arm will be administered treated with the study device. It will be 10 mW\u002Fcm\\^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.",[13],"Device: Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DEVICE","Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Onajovwe Fofah, Medical","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Garrett Gianneschi, Medical","CONTACT","908-294-1161","garrettgianneschi@gmail.com",{"name":22,"role":27,"phone":31,"phoneExt":19,"email":32},"973-972-6753","fofahon@njms.rutgers.edu",[34,55],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Rutgers - New Jersey Medical School \u002F University Hospital","RECRUITING","Newark","New Jersey","07103","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-74.17237,40.73566,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":19,"email":52},"Garrett Gianneschi, DO","9082941161","gbg30@rutgers.edu",{"name":54,"role":23,"phone":19,"phoneExt":19,"email":19},"Bellipady Rai, MD",{"facility":56,"status":36,"city":37,"state":38,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Newark Beth Israel Medical Center","07112",{"type":43,"coordinates":59},[45,46],{"lat":46,"lon":45},[62,64],{"name":63,"role":27,"phone":51,"phoneExt":19,"email":52},"Garrett Gianneschi",{"name":65,"role":23,"phone":19,"phoneExt":19,"email":19},"Onajovwe Fofah, MD",{"type":23,"investigatorFullName":65,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Department of Pediatrics Chair","100577355","light-therapy-device-for-neonatal-intraventricular-hemorrhage-grade-3-and-4-100577355",false,"NCT06797219","Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4","EFIL","Inclusion Criteria:\n\n* neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.\n\nExclusion Criteria:\n\n* neonates without IVH grade 3\u002F4 or older than 1 month.","ALL","0 Days","1 Month",{"count":79,"type":80},24,"ESTIMATED","INTERVENTIONAL",[83],"NA","The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\\' experience with the study intervention. A complete list of objectives and aims are listed under \"Objectives\". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW\u002Fcm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.",[86,87],"Intraventricular Hemorrhage of Prematurity","Hydrocephalus",[89,90,91,92],"low level laser therapy","neonate","developmental milestones","intraventricular hemorrhage","2025-07-16",{"date":95,"type":96},"2025-07-22","ACTUAL",{"date":98,"type":96},"2025-02-25",{"date":100,"type":80},"2028-07-31",{"name":5,"class":6},2]