An interventional study of Concrete household floor in Stillbirth and Neonatal Mortality, Perinatal Mortality and Infant Mortality, sponsored by Stanford University. Not yet recruiting at 1 site in Bangladesh. Open to participants aged Up to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?
Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.
This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.
This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).
Inclusion Criteria:
Household soil floors will be replaced with concrete floors
Other: Concrete household floor
Household soil floors will be replaced with concrete floors
Extended perinatal mortality rate
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) and neonatal deaths within the first 28 days after birth divided by the number of total births (live births + stillbirths)
Time frame: Up to 6 years post-intervention delivery in parent study
Stillbirth rate
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) divided by the number of total births (live births + stillbirths)
Time frame: Up to 6 years post-intervention delivery in parent study
Early neonatal mortality rate
Total number of deaths occurring in the first 7 days of life divided by the number of live births
Time frame: Up to 6 years post-intervention delivery in parent study
Neonatal mortality rate
Total number of deaths occurring in the first 28 days of life divided by the number of live births
Time frame: Up to 6 years post-intervention delivery in parent study
Infant mortality rate
Total deaths prior to age 12 months among live births divided by total live births
Time frame: Up to 6 years post-intervention delivery in parent study
Child mortality rate
Total deaths at any age among live births divided by total live births
Time frame: Up to 6 years post-intervention delivery in parent study
Plan to share: Yes — All human subjects data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. All data will be made available at the individual level (outcomes, covariates) or household level (in the case of the household survey variables, i.e. wealth).
Supporting information: Study protocol, Sap, Analytic code
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Stanford University