[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579442":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":42,"locations":51,"responsibleParty":80,"collaborators":82,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":26,"maxAge":26,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of California, Berkeley","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Control group. At the conclusion of the trial, facilities will receive a chlorine doser.",[13],"Behavioral: infection prevention and control messaging",{"label":15,"type":16,"description":17,"interventionNames":18},"Multi-component chlorine intervention","EXPERIMENTAL","Health care facilities will receive one or more inline chlorine dosers that will automatically chlorinate all water accessed by the maternity wards. Intervention facilities will also be randomized to either receive an electrochlorinator for on-site production of liquid chlorine solution or to receive bulk chlorine deliveries. Chlorine will be use to refill the chlorine dosers and for surface disinfection. Facilities will also receive hardware to facilitate surface disinfection.",[19,13],"Device: chlorination for water disinfection and surface disinfection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","chlorination for water disinfection and surface disinfection","* Installation of inline chlorine doser(s) for automated water disinfection.\n* Provision of chlorine solution for water and surface disinfection (half of treatment facilities randomized to receive electrochlorinator, half receive bulk chlorine solution deliveries).\n* Provision of mop(s), bucket(s), and spray bottles for surface cleaning.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","infection prevention and control messaging","Infection prevention and control guidance and messaging",[9,15],[33,36,39],{"name":34,"affiliation":5,"role":35},"Amy J Pickering, PhD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Phelgona Otieno, PhD","Kenya Medical Research Institute",{"name":40,"affiliation":41,"role":35},"Lillian Musila, PhD","Walter Reed Army Institute of Research-Africa",[43,47],{"name":34,"role":44,"phone":45,"phoneExt":26,"email":46},"CONTACT","1-510-410-2666","amyjanel@gmail.com",{"name":48,"role":44,"phone":49,"phoneExt":26,"email":50},"Yoshika Crider, PhD","1-785-550-5227","ycrider@berkeley.edu",[52,65],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":26},"ACTIVE_NOT_RECRUITING","Berkeley","California","94720","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-122.27275,37.87159,{"lat":63,"lon":62},{"facility":38,"status":66,"city":67,"state":26,"zip":26,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"RECRUITING","Nairobi","Kenya","KE",{"type":60,"coordinates":71},[72,73],36.81667,-1.28333,{"lat":73,"lon":72},[76,79],{"name":37,"role":44,"phone":77,"phoneExt":26,"email":78},"+254-721973971","phelgona@gmail.com",{"name":37,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":81,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[83,86,87],{"name":84,"class":85},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":38,"class":6},{"name":88,"class":89},"Walter Reed Army Institute of Research (WRAIR)","FED","100579442","clean-trial---chlorination-to-reduce-enteric-and-antibiotic-resistant-infections-in-neonates-100579442",false,"NCT06824350","Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates","Multi-component Chlorination Intervention to Reduce Neonatal Infections in Rural Health Facilities","CLEAN","Facility Inclusion Criteria:\n\n* Public health care facility\n* 25 live births or more per month\n* Infrastructure compatible with inline chlorination device\n\nParticipant Inclusion Criteria:\n\n* Pregnant adults\u002Fmature minors arriving at enrolled facilities to give birth and their neonates\n\nFacility Exclusion Criteria:\n\n* Existing facility-level chlorination\n\nParticipant Exclusion Criteria:\n\n* Miscarriage (\\\u003C28 weeks gestation)\n* Stillbirth (for neonatal analysis only)\n* Unable to give informed consent\u002Fdo not consent\n* Reside \\>2 hours away from facility for enrollment into swab sampling cohort",true,"ALL",{"count":101,"type":102},45450,"ESTIMATED","INTERVENTIONAL",[105],"NA","The CLEAN (ChLorine to reduce Enteric and Antibiotic resistant infections in Neonates) cluster randomized controlled trial in western Kenya will evaluate the impact of a multi-component chlorination intervention in health care facilities on maternal and neonatal health. Intervention facilities will receive a passive chlorination technology for water supply treatment and a reliable supply of sodium hypochlorite disinfectant. Both intervention and treatment facilities will receive infection prevention and control messaging. The goal of the study is to evaluate the impact of the intervention on bacterial contamination of water supply, on staff hands, and on high-touch surfaces in maternity wards, and the following outcomes among facility-born neonates and their mothers: (1) gut carriage of bacterial pathogens associated with sepsis one week post-birth, (2) gut carriage of antibiotic resistant bacteria one week post-birth, and (3) symptoms of possible serious bacterial infection one week following birth.",[108,109,110,111,112],"Sepsis","Neonatal Mortality","Antibiotic Resistant Infection","Enteric Infections","Serious Bacterial Infection",[114,115,116,117,118,119,120,121,122],"infection prevention and control","antibiotic resistance","bacterial enteric infection","neonatal mortality","sepsis","water disinfection","chlorine","sodium hypochlorite","hospital acquired infections","2025-05-20",{"date":125,"type":126},"2025-05-25","ACTUAL",{"date":128,"type":126},"2025-01-21",{"date":130,"type":102},"2027-07",{"name":5,"class":6},2]