Perinatal Mortality Outcomes Through Household Infection Pathways

NCT07620613 | Not Yet Recruiting

• 2 other identifiers: 8628903001
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

concrete floor; soil floor; dirt floor; housing intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 6 years post-intervention delivery in parent study

Secondary Outcomes (5)

• Stillbirth rate

  Up to 6 years post-intervention delivery in parent study

• Early neonatal mortality rate

  Up to 6 years post-intervention delivery in parent study

• Neonatal mortality rate

  Up to 6 years post-intervention delivery in parent study

• Infant mortality rate

  Up to 6 years post-intervention delivery in parent study

• Child mortality rate

  Up to 6 years post-intervention delivery in parent study

Study Arms (2)

Concrete household floor

EXPERIMENTAL

Household soil floors will be replaced with concrete floors

Other: Concrete household floor

Non-intervention

NO INTERVENTION

Interventions

Concrete household floor OTHER

Household soil floors will be replaced with concrete floors

Concrete household floor

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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 plan to relocate within the study follow-up period
• Incident pregnancy occurring after CRADLE trial enrollment, confirmed at 13-30 weeks gestation

Sponsors & Collaborators

• Stanford University: lead
• Thrasher Research Fund: collaborator
• North Carolina State University: collaborator
• Directorate General of Health Services, Bangladesh: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

Related Publications (1)

• Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain S, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol. medRxiv [Preprint]. 2024 Jul 27:2024.07.26.24311076. doi: 10.1101/2024.07.26.24311076.

  PMID: 39108529 BACKGROUND

Related Links

• Parent trial Clinicaltrials.gov registration

MeSH Terms

Conditions

Stillbirth; Perinatal Death; Infant Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jade Benjamin-Chung, PhD MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology and Population Health

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified data will be made publicly available within 2 years of the end of the study or at the time of publication, whichever is sooner.
• Access Criteria: To be determined

Locations

BA (1)