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BMJ open
Mar 03, 2025;15 (3): e090703.

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 Kashem Shoab, Jason R Andrews, Ying Lu, Sarah Billington, Nils Pilotte, Ireen S Shanta, Mohammed Jubair, Mustafizur Rahman, Mamun Kabir, Rashidul Haque, Fahmida Tofail, Md 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, Dhaka, Bangladesh.
  2. Farjana Jahan: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  3. Suhi Hanif: King Center on Global Development, Stanford University, Stanford, California, USA.
  4. Afsana Yeamin: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  5. Abul Kashem Shoab: Environmental Health and WASH, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  6. Jason R Andrews: Division of Infectious Diseases and Geographic Medicine, Stanford University, Stanford, California, USA. ORCID
  7. Ying Lu: Department of Biomedical Data Science, Stanford University, Stanford, California, USA.
  8. Sarah Billington: Department of Civil and Environmental Engineering, Stanford University, Stanford, California, USA.
  9. Nils Pilotte: Department of Biological Sciences, Quinnipiac University, Hamden, Connecticut, USA.
  10. Ireen S Shanta: Division of Infectious Diseases, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  11. Mohammed Jubair: Genome Centre Infectious Diseases Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  12. Mustafizur Rahman: Genome Centre Infectious Diseases Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  13. Mamun Kabir: Division of Infectious Diseases, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  14. Rashidul Haque: Centre for Communicable Diseases, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  15. Fahmida Tofail: Maternal and Child Nutrition, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  16. Md Sakib Hossain: Laboratory of Environmental Health, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh. ORCID
  17. Zahid H Mahmud: Laboratory of Environmental Health, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, Bangladesh.
  18. Ayse Ercumen: College of Natural Resources, North Carolina State University, Raleigh, North Carolina, USA.
  19. Jade Benjamin-Chung: Department of Epidemiology and Population Health, Stanford University, Stanford, California, USA jadebc@stanford.edu. ORCID
PMID: 40032381 DOI: 10.1136/bmjopen-2024-090703

Abstract

INTRODUCTION: Early life soil-transmitted helminth (STH) infection and diarrhoea are associated with growth faltering, anaemia, impaired child development and mortality. Exposure to faecally 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 STH infection and other maternal and child health outcomes in rural Bangladesh.
METHODS AND ANALYSIS: The Cement-based flooRs AnD chiLd hEalth 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 and no plan to relocate for 3 years will be eligible. We will randomise 800 households to intervention or control (1:1) within geographical blocks of 10 households to account for strong geographical clustering of enteric infection. Laboratory staff and data analysts will be blinded; participants will be unblinded. We will instal 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 STH infection (, or ) detected by quantitative PCR 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 STH DNA; child diarrhoea, 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. We will report findings on ClinicalTrials.gov, in peer-reviewed publications and in stakeholder workshops in Bangladesh.
TRIAL REGISTRATION NUMBER: NCT05372068.

Keywords

Community child health Paediatric infectious disease & immunisation Public health

Associated Data

ClinicalTrials.gov | NCT05372068

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Grants

  1. R01 HD108196/NICHD NIH HHS

MeSH Term

Humans
Bangladesh
Female
Helminthiasis
Child Health
Child, Preschool
Floors and Floorcoverings
Soil
Diarrhea
Randomized Controlled Trials as Topic
Rural Population
Pregnancy
Maternal Health
Construction Materials
Infant

Chemicals

Soil
Journal Article Clinical Trial Protocol Randomized Controlled Trial
Article has an altmetric score of 1

Word Cloud

Created with Highcharts 10.0.0childwillfloorsSTHinfectionsoilBangladeshtrialconcretematernalhealthoutcomesdiarrhoeagrowthdevelopmententericruralhomesmeasureANDrandomisedfloor3householdsgeographicalbirthcohort6121824monthshouseholdINTRODUCTION:Earlylifesoil-transmittedhelminthassociatedfalteringanaemiaimpairedmortalityExposurefaecallycontaminatedinsidehomemaykeycontributorinfectionslargefractionlow-incomecountriesobjectivestudyeffectinstallingMETHODSANALYSIS:Cement-basedflooRsAnDchiLdhEalthindividuallySirajganjTangaildistrictsHouseholdspregnantwomanwallsmademudplanrelocateyearseligiblerandomise800interventioncontrol1:1withinblocks10accountstrongclusteringLaboratorystaffdataanalystsblindedparticipantsunblindedinstaluteroagesprimaryoutcomeprevalencedetectedquantitativePCRfollow-upSecondaryincludehandcontaminationextended-spectrumbeta-lactamaseproducingDNAcognitivestressdepressionETHICSDISSEMINATION:StudyprotocolsapprovedinstitutionalreviewboardsStanfordUniversityInternationalCentreDiarrhealDiseaseResearchreportfindingsClinicalTrialsgovpeer-reviewedpublicationsstakeholderworkshopsTRIALREGISTRATIONNUMBER:NCT05372068Effectshealth:CRADLE-controlledprotocolCommunityPaediatricinfectiousdisease&immunisationPublic

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