Perinatal Mortality Outcomes Through Household Infection Pathways
Starting soon · Not applicable
Conditions studied: Stillbirth and Neonatal Mortality, Perinatal Mortality, Infant Mortality, Child Mortality
In brief
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.
Key facts
- Study ID
- NCT07620613
- Run by
- Stanford University
- People needed
- 196
- Starts
- 2026-06-01
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: any, up to 6. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household
- Residence in Sirajganj or Tangail districts in Bangladesh
- No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)
- No plan to relocate within the study follow-up period
- Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation
Where it is running
- International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka, Bangladesh
Full record on ClinicalTrials.gov
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