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Jul 27, 2024;

Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol.

Mahbubur Rahman, Farjana Jahan, Suhi Hanif, Afsana Yeamin, Abul Kasham Shoab, Jason R Andrews, Ying Lu, Sarah Billington, Nils Pilotte, Ireen S Shanta, Mohammad Jubair, Mustafizur Rahman, Mamun Kabir, Rashidul Haque, Fahmida Tofail, Sakib Hossain, Zahid H Mahmud, Ayse Ercumen, Jade Benjamin-Chung
Author Information
  1. Mahbubur Rahman: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b),Dhaka-1212, Bangladesh.
  2. Farjana Jahan: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b),Dhaka-1212, Bangladesh.
  3. Suhi Hanif: King Center on Global Development, Stanford University.
  4. Afsana Yeamin: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b),Dhaka-1212, Bangladesh.
  5. Abul Kasham Shoab: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b),Dhaka-1212, Bangladesh.
  6. Jason R Andrews: Division of Infectious Diseases and Geographic Medicine, Stanford University.
  7. Ying Lu: Department of Biomedical Data Science, Stanford University.
  8. Sarah Billington: Department of Civil and Environmental Engineering, Stanford University.
  9. Nils Pilotte: Department of Biological Sciences, Quinnipiac University.
  10. Ireen S Shanta: Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh.
  11. Mohammad Jubair: Genome Centre Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh.
  12. Mustafizur Rahman: Genome Centre Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh.
  13. Mamun Kabir: Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh.
  14. Rashidul Haque: Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Bangladesh.
  15. Fahmida Tofail: Maternal and Child Nutrition, International Centre for Diarrhoeal Disease Research, Bangladesh.
  16. Sakib Hossain: Laboratory of Environmental Health, International Centre for Diarrhoeal Disease Research, Bangladesh.
  17. Zahid H Mahmud: Laboratory of Environmental Health, International Centre for Diarrhoeal Disease Research, Bangladesh.
  18. Ayse Ercumen: College of Natural Resources, North Carolina State University.
  19. Jade Benjamin-Chung: Department of Epidemiology and Population Health, Stanford University and Chan Zuckerberg Biohub Investigator. ORCID
PMID: 39108529 DOI: 10.1101/2024.07.26.24311076

Abstract

Introduction: Early life soil-transmitted helminth infection and diarrhea are associated with growth faltering, anemia, impaired chiLd development, and mortality. Exposure to fecally contaminated soil inside the home may be a key contributor to enteric infections, and a large fraction of rural homes in low-income countries have soil floors. The objective of this study is to measure the effect of installing concrete floors in homes with soil floors on chiLd soil-transmitted helminth infection and other maternal and chiLd health outcomes in rural Bangladesh.
Methods and analysis: The Cement-based flooRs AnD chiLd hEalth (CRADLE) trial is an individually randomised trial in Sirajganj and Tangail districts, Bangladesh. Households with a pregnant woman, a soil floor, walls that are not made of mud will be eligible, and no plan to relocate for 3 years. We will randomise 800 households to intervention or control (1:1) within geographic blocks of 10 households to account for strong geographic clustering of enteric infection. Laboratory staff and data analysts will be blinded; participants will be unblinded. We will install concrete floors when the birth cohort is in utero and measure outcomes at chiLd ages 3, 6, 12, 18, and 24 months. The primary outcome is prevalence of any soil-transmitted helminth infection (, or ) detected by qPCR at 6, 12, 18, or 24 months follow-up in the birth cohort. Secondary outcomes include household floor and chiLd hand contamination with , extended-spectrum beta-lactamase producing , and soil-transmitted helminth DNA; chiLd diarrhea, growth, and cognitive development; and maternal stress and depression.
Ethics and dissemination: Study protocols have been approved by institutional review boards at Stanford University and the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b). We will report findings on ClinicalTrials.gov, in peer-reviewed publications, and in stakeholder workshops in Bangladesh.
Trial registration number: NCT05372068, pre-results.

Associated Data

ClinicalTrials.gov | NCT05372068

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Grants

  1. R01 HD108196/NICHD NIH HHS
Journal Article Preprint
Article has an altmetric score of 1

Word Cloud

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