[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630503":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":43,"collaborators":45,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":19,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":75,"whyStopped":19,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Swiss Tropical & Public Health Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Gazelle-Multispectral for newborn sickle cell disease screening; and early clinical interventions","EXPERIMENTAL","A novel multifaceted intervention composed of: 1) integration of Gazelle-Multispectral point of care testing (POCT) for newborn sickle cell disease (SCD) screening; and 2) initiation of early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea and parental education about SCD medical care.",[13],"Combination Product: Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"COMBINATION_PRODUCT","Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Acellam Charles Abongomera, MD, MPH, PhD","CONTACT","+41612848629","charles.abongomera@swisstph.ch",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Benjamin Koudou, PhD","+2250777205263","guibehi.koudou@csrs.ci",[31],{"facility":32,"status":19,"city":33,"state":19,"zip":19,"country":34,"countryCode":19,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Yopougon SCD Center of Excellence","Yopougon","Côte d’Ivoire",{"type":36,"coordinates":37},"Point",[38,39],-4.08669,5.37477,{"lat":39,"lon":38},[42],{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[46,48],{"name":47,"class":6},"Centre Suisse de Recherches Scientifiques en Cote d'Ivoire",{"name":49,"class":50},"Novartis Pharma AG, Switzerland","UNKNOWN","100630503","phase-4-integrating-point-of-care-testing-poct-for-newborn-screening-and-early-care-for-sickle-cell-disease-in-yopougon-cte-divoire-100630503",false,"NCT07488520","Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire","STEP","Inclusion Criteria:\n\n1. Children aged 0 - 6 months old identified at selected health facilities within the study area\n2. Babies whose age plus the gestation period reaches 37 weeks or more\n3. Children who did not receive a blood transfusion within the past 90 days\n4. Children whose parents or guardians have consented to participate in the study by signing a consent form\n\nExclusion Criteria:\n\n1. Children already diagnosed with SCD\n2. Children that are participating in another clinical research project\n3. Children that are critically ill and require emergency treatment","ALL","0 Months","6 Months",{"count":62,"type":63},120,"ESTIMATED","INTERVENTIONAL",[66],"PHASE4","The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes.\n\nThe main questions it aims to answer are:\n\n* Does the intervention lower the number of SCD-related illnesses?\n* Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness?\n* Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)?\n\nResearchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region.\n\nParticipants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.",[69],"Sickle Cell Disease (SCD)",[71,72,73,74],"Sickle cell disease","Newborn Screening","Early Care for Sickle Cell Disease","Point of care testing","NOT_YET_RECRUITING","2026-03-18",{"date":78,"type":79},"2026-03-23","ACTUAL",{"date":81,"type":63},"2026-04",{"date":83,"type":63},"2029-12",{"name":5,"class":6},1]