Cement flooRs AnD chiLd hEalth (CRADLE)

Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diarrhea; Necator Americanus Infection; Ascaris Lumbricoides Infection; Trichuris Trichiura; Infection
• Intervention / Treatment: Other: Concrete household floor

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Home is not strictly residential (e.g., includes a business)
• Household with walls made of mud/soil
• Household floor size > 500 square feet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concrete household floor	Other: Concrete household floor; Household soil floors will be replaced with concrete floors
No Intervention: Non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child diarrhea prevalence	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	Up to 24 months
Child Ascaris lumbricoides infection prevalence	Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up	Up to 24 months
Child Necator americanus infection prevalence	Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up	Up to 24 months
Child Trichuris trichiura infection prevalence	Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up	Up to 24 months
Culturable E. coli abundance in household floor samples	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)	Up to 24 months
Culturable E. coli abundance in child hand rinse samples	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)	Up to 24 months
Ascaris lumbricoides prevalence in household floor samples	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)	Up to 24 months
Necator americanus prevalence in household floor samples	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)	Up to 24 months
Trichuris trichiura prevalence in household floor samples	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)	Up to 24 months
Any soil-transmitted helminth prevalence in household floor samples	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)	Up to 24 months
Culturable cefotaxime-resistant E. coli prevalence in household floor samples	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)	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascaris lumbricoides prevalence in household floor samples	Prevalence of Ascaris lumbricoides detected in household floor swabs with qPCR at any follow-up measurement through month 24	Up to 24 months
Trichuris trichiura prevalence in household floor samples	Prevalence of Trichuris trichiura detected in household floor swabs with qPCR at any follow-up measurement through month 24	Up to 24 months
Any soil-transmitted helminth prevalence in household floor samples	Prevalence of Ascaris lumbricoides or Trichuris trichiura detected in household floor swabs with qPCR at any follow-up measurement through month 24	Up to 24 months
Culturable E. coli prevalence in household floor samples	Prevalence of E. coli in household floor swabs detected with IDEXX at any follow-up measurement in a sub-sample of households at any follow-up measurement through month 24	Up to 24 months
Prevalence of other enteric pathogen carriage in household floor samples	Prevalence of other enteric pathogens in household floor samples detected using a TaqMan array card in a sub-sample of households at any follow-up measurement through month 24	Up to 24 months
Frequency of child soil contact	Mean number of child soil contact events per hour measured using video observations in a sub-sample of the birth cohort at each follow-up measurement through month 24	Up to 24 months
Frequency of child soil ingestion	Mean number of child soil ingestion events per hour measured using video observations in a sub-sample of the birth cohort at each follow-up measurement through month 24	Up to 24 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); International Centre for Diarrhoeal Disease Research, Bangladesh; North Carolina State University; Stanford Woods Institute for the Environment; Directorate General of Health Services, Bangladesh
• Investigators: Principal Investigator: Jade Benjamin-Chung, PhD MPH, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infections; Parasitic Diseases; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Diarrhea; Trichuriasis
• Other Study ID Numbers: 63990; R01HD108196 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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).
• IPD Sharing 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.
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No