[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637574":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":38,"studyPopulation":29,"armGroups":39,"interventions":49,"overallOfficials":52,"centralContacts":29,"locations":56,"responsibleParty":71,"collaborators":74,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":29,"maxAge":93,"enrollmentInfo":94,"targetDuration":29,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":111,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Extended perinatal mortality rate","Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) and neonatal deaths within the first 28 days after birth divided by the number of total births (live births + stillbirths)","Up to 6 years post-intervention delivery in parent study",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Stillbirth rate","Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) divided by the number of total births (live births + stillbirths)",{"measure":18,"description":19,"timeFrame":12},"Early neonatal mortality rate","Total number of deaths occurring in the first 7 days of life divided by the number of live births",{"measure":21,"description":22,"timeFrame":12},"Neonatal mortality rate","Total number of deaths occurring in the first 28 days of life divided by the number of live births",{"measure":24,"description":25,"timeFrame":12},"Infant mortality rate","Total deaths prior to age 12 months among live births divided by total live births",{"measure":27,"description":28,"timeFrame":12},"Child mortality rate","Total deaths at any age among live births divided by total live births",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":35,"maskingDescription":29,"whoMasked":36},"SINGLE",[37],"INVESTIGATOR","This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Concrete household floor","EXPERIMENTAL","Household soil floors will be replaced with concrete floors",[45],"Other: Concrete household floor",{"label":47,"type":48,"description":29,"interventionNames":29},"Non-intervention","NO_INTERVENTION",[50],{"type":6,"name":41,"description":43,"armGroupLabels":51,"otherNames":29},[41],[53],{"name":54,"affiliation":5,"role":55},"Jade Benjamin-Chung, PhD MPH","PRINCIPAL_INVESTIGATOR",[57],{"facility":58,"status":29,"city":59,"state":29,"zip":29,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"International Centre for Diarrhoeal Disease Research, Bangladesh","Dhaka","Bangladesh","BD",{"type":63,"coordinates":64},"Point",[65,66],90.40744,23.7104,{"lat":66,"lon":65},[69],{"name":70,"role":55,"phone":29,"phoneExt":29,"email":29},"Md. Mahbubur Rahman, MBBS",{"type":55,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Jade Benjamin-Chung","Assistant Professor of Epidemiology and Population Health",[75,77,78,80],{"name":76,"class":6},"Thrasher Research Fund",{"name":58,"class":6},{"name":79,"class":6},"North Carolina State University",{"name":81,"class":82},"Directorate General of Health Services, Bangladesh","OTHER_GOV","100637574","perinatal-mortality-outcomes-through-household-infection-pathways-100637574",false,"NCT07620613","Perinatal Mortality Outcomes Through Household Infection Pathways","Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh","POTH","Inclusion Criteria:\n\n* Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household\n* Residence in Sirajganj or Tangail districts in Bangladesh\n* No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)\n* No plan to relocate within the study follow-up period\n* Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation",true,"ALL","6 Years",{"count":95,"type":96},196,"ESTIMATED","INTERVENTIONAL",[99],"NA","The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?\n\nResearchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.\n\nThis study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.",[102,103,104,105],"Stillbirth and Neonatal Mortality","Perinatal Mortality","Infant Mortality","Child Mortality",[107,108,109,110],"concrete floor","soil floor","dirt floor","housing intervention","NOT_YET_RECRUITING","2026-06-27",{"date":114,"type":115},"2026-07-01","ACTUAL",{"date":117,"type":96},"2026-06-01",{"date":119,"type":96},"2029-05-01",{"name":5,"class":6},1]