Cement flooRs AnD chiLd hEalth (CRADLE)
2 other identifiers
interventional
800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
September 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
April 28, 2026
April 1, 2026
3.4 years
May 6, 2022
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Child prevalence of any soil-transmitted helminth infection
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
Up to 24 months
Secondary Outcomes (11)
Child Ascaris lumbricoides infection prevalence
Up to 24 months
Child Necator americanus infection prevalence
Up to 24 months
Child Trichuris trichiura infection prevalence
Up to 24 months
Child diarrhea prevalence
Up to 24 months
Ascaris lumbricoides prevalence in household floor samples
Up to 24 months
- +6 more secondary outcomes
Study Arms (2)
Concrete household floor
EXPERIMENTALNon-intervention
NO INTERVENTIONInterventions
Household soil floors will be replaced with concrete floors
Eligibility Criteria
You may qualify if:
- Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh
- No plan to relocate in the next 2-3 years
- Reside in home with floors made entirely of soil
- Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment
You may not qualify if:
- Home is not strictly residential (e.g., includes a business)
- Household with walls made of mud/soil
- Household floor size \> 500 square feet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- North Carolina State Universitycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- International Centre for Diarrhoeal Disease Research, Bangladeshcollaborator
- Directorate General of Health Services, Bangladeshcollaborator
- Stanford Woods Institute for the Environmentcollaborator
Study Sites (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh
Related Publications (2)
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: 40032381DERIVEDRahman 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.
PMID: 39108529DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jade Benjamin-Chung, PhD MPH
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Epidemiology & Population Health
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 12, 2022
Study Start
September 24, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- 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.
- Access Criteria
- To be determined
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).