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

Abstract

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. 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 (<i>Ascaris lumbricoides</i>, <i>Necator americanus</i> or <i>Trichuris trichiura</i>) 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 <i>Escherichia coli</i>, extended-spectrum beta-lactamase producing <i>E. coli</i> and STH DNA; child diarrhoea, growth and cognitive development; and maternal stress and depression. 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. NCT05372068.