Cement flooRs AnD chiLd hEalth (CRADLE)

Stanford University

Status: Active, not recruiting

Conditions: Diarrhea; Necator Americanus Infection; Trichuris Trichiura; Infection; Ascaris Lumbricoides Infection

Treatments: Other: Concrete household floor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05372068

R01HD108196 (U.S. NIH Grant/Contract)

63990

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups

Concrete household floor

Experimental group

Treatment:

Other: Concrete household floor

Non-intervention

No Intervention group