Clinical trial NCT05372068: Cement flooRs AnD chiLd hEalth (CRADLE)
Official title: Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ascaris Lumbricoides Infection
Necator Americanus Infection
Trichuris Trichiura; Infection
Diarrhea
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: North Carolina State University
name: Soil Transmitted Helminthiasis Control Program, Directorate General of Health Services, Bangladesh
name: Stanford Woods Institute for the Environment
First posted: 2022-05-12
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child prevalence of any soil-transmitted helminth infection
timeFrame: Up to 24 months
Secondary outcomes:
measure: Child Ascaris lumbricoides infection prevalence
timeFrame: Up to 24 months
measure: Child Necator americanus infection prevalence
timeFrame: Up to 24 months
measure: Child Trichuris trichiura infection prevalence
timeFrame: Up to 24 months
measure: Child diarrhea prevalence
timeFrame: Up to 24 months
measure: Ascaris lumbricoides prevalence in household floor samples
timeFrame: Up to 24 months
measure: Necator americanus prevalence in household floor samples
timeFrame: Up to 24 months
measure: Trichuris trichiura prevalence in household floor samples
timeFrame: Up to 24 months
measure: Any soil-transmitted helminth prevalence in household floor samples
timeFrame: Up to 24 months
measure: Culturable E. coli abundance in household floor samples
timeFrame: Up to 24 months
measure: Culturable E. coli abundance in child hand rinse samples
timeFrame: Up to 24 months
measure: Culturable cefotaxime-resistant E. coli prevalence in household floor samples
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: Stanford University
name: Jade Benjamin-Chung, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: