Cement flooRs AnD chiLd hEalth (CRADLE)

Not Applicable

Active, not recruiting

• Conditions: Trichuris Trichiura; Infection; Necator Americanus Infection; Ascaris Lumbricoides Infection; Diarrhea
• Interventions: Other: Concrete household floor

• Registration Number: NCT05372068
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-12
• Study Start: 2023-09-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concrete household floor	Concrete household floor	-

Primary Outcome Measures

Name	Time	Method
Child prevalence of any soil-transmitted helminth infection	Up to 24 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh