Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-27 @ 12:35 AM
Study NCT ID:
NCT05372068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cement flooRs AnD chiLd hEalth (CRADLE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014257', 'term': 'Trichuriasis'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child prevalence of any soil-transmitted helminth infection', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Child Ascaris lumbricoides infection prevalence', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up'}, {'measure': 'Child Necator americanus infection prevalence', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up'}, {'measure': 'Child Trichuris trichiura infection prevalence', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up'}, {'measure': 'Child diarrhea prevalence', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of diarrhea is defined as 3 or more loose or watery stools in 24 hours or 1 or more stools with blood in 24 hours at any follow-up measurement. Diarrhea will be based on caregiver-reported symptoms in the birth cohort with 2-day and 7-day recall at any follow-up measurement through month 24'}, {'measure': 'Ascaris lumbricoides prevalence in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Ascaris lumbricoides in household floor dust detected with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Necator americanus prevalence in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Necator americanus detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Trichuris trichiura prevalence in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Any soil-transmitted helminth prevalence in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Culturable E. coli abundance in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Abundance (most probable number per square meter) of E. coli in household floor swabs detected with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Culturable E. coli abundance in child hand rinse samples', 'timeFrame': 'Up to 24 months', 'description': 'Abundance (most probable number per two hands) of E. coli on child hands enumerated with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}, {'measure': 'Culturable cefotaxime-resistant E. coli prevalence in household floor samples', 'timeFrame': 'Up to 24 months', 'description': 'Prevalence of cefotaxime-resistant E. coli in household floor swabs detected with a modified IDEXX protocol with cefotaxime supplement in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ascaris Lumbricoides Infection', 'Necator Americanus Infection', 'Trichuris Trichiura; Infection', 'Diarrhea']}, 'referencesModule': {'references': [{'pmid': '40032381', 'type': 'DERIVED', 'citation': 'Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain MS, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health: the CRADLE trial - a randomised controlled trial protocol. BMJ Open. 2025 Mar 3;15(3):e090703. doi: 10.1136/bmjopen-2024-090703.'}, {'pmid': '39108529', 'type': 'DERIVED', 'citation': 'Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain S, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol. medRxiv [Preprint]. 2024 Jul 27:2024.07.26.24311076. doi: 10.1101/2024.07.26.24311076.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh\n* No plan to relocate in the next 2-3 years\n* Reside in home with floors made entirely of soil\n* Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment\n\nExclusion Criteria:\n\n* Home is not strictly residential (e.g., includes a business)\n* Household with walls made of mud/soil\n* Household floor size \\> 500 square feet'}, 'identificationModule': {'nctId': 'NCT05372068', 'briefTitle': 'Cement flooRs AnD chiLd hEalth (CRADLE)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh', 'orgStudyIdInfo': {'id': '63990'}, 'secondaryIdInfos': [{'id': 'R01HD108196', 'link': 'https://reporter.nih.gov/quickSearch/R01HD108196', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concrete household floor', 'interventionNames': ['Other: Concrete household floor']}, {'type': 'NO_INTERVENTION', 'label': 'Non-intervention'}], 'interventions': [{'name': 'Concrete household floor', 'type': 'OTHER', 'description': 'Household soil floors will be replaced with concrete floors', 'armGroupLabels': ['Concrete household floor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Jade Benjamin-Chung, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'De-identified data will be made publicly available within 2 years of the end of the study or at the time of publication, whichever is sooner.', 'ipdSharing': 'YES', 'description': 'All human subjects and environmental data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. Coded data from videos will be made public, but videos will not be published in order to protect participant privacy. All data will be made available at the individual level (or household level, in the case of the household survey).', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}, {'name': 'North Carolina State University', 'class': 'OTHER'}, {'name': 'Soil Transmitted Helminthiasis Control Program, Directorate General of Health Services, Bangladesh', 'class': 'UNKNOWN'}, {'name': 'Stanford Woods Institute for the Environment', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Epidemiology & Population Health', 'investigatorFullName': 'Jade Benjamin-Chung', 'investigatorAffiliation': 'Stanford University'}}}}