Perinatal Mortality Outcomes Through Household Infection Pathways

ConditionsStillbirth and Neonatal Mortality Perinatal Mortality Infant Mortality Child Mortality

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Concrete household floor
Other intervention
Household soil floors will be replaced with concrete floors

Treatment groups

196 Participants

are divided into 2 treatment groups

Group A: Concrete household floorExperimental treatment 1 intervention

Group B: Non-interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

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