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Perinatal Mortality Outcomes Through Household Infection Pathways

NCT07620613 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-07-01

No results posted yet for this study

Summary

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.

Conditions

  • Stillbirth and Neonatal Mortality
  • Perinatal Mortality
  • Infant Mortality
  • Child Mortality

Interventions

OTHER

Concrete household floor

Household soil floors will be replaced with concrete floors

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • North Carolina State University

    collaborator OTHER

  • Directorate General of Health Services, Bangladesh

    collaborator OTHER_GOV

  • Stanford University

    lead OTHER

Principal Investigators

  • Jade Benjamin-Chung, PhD MPH · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-03-01
Completion
2029-05-01

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620613 on ClinicalTrials.gov