Perinatal Mortality Outcomes Through Household Infection Pathways

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorStanford University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Concrete household floor

Treatment groups

196 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

Thrasher Research Fund

Collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborator

North Carolina State University

Collaborator

Directorate General of Health Services, Bangladesh

Collaborator