Cement flooRs AnD chiLd hEalth (CRADLE)

Not Applicable

Active, not recruiting

• Conditions: Trichuris Trichiura; Infection; Necator Americanus Infection; Ascaris Lumbricoides Infection; Diarrhea
• Interventions: Other: Concrete household floor

• Registration Number: NCT05372068
• Lead Sponsor: Stanford University

Brief Summary

This randomized trial in rural Bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. The trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. The study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-12
• Study Start: 2023-09-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-08
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Residence in Chauhali upazila or adjacent upazilas in Sirajganj or Tangail districts in Bangladesh
• No plan to relocate in the next 2-3 years
• Reside in home with floors made entirely of soil
• Pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment

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Exclusion Criteria

• Home is not strictly residential (e.g., includes a business)
• Household with walls made of mud/soil
• Household floor size > 500 square feet

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concrete household floor	Concrete household floor	-

Primary Outcome Measures

Name	Time	Method
Child prevalence of any soil-transmitted helminth infection	Up to 24 months	Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up

Secondary Outcome Measures

Name	Time	Method
Child Ascaris lumbricoides infection prevalence	Up to 24 months	Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Child Necator americanus infection prevalence	Up to 24 months	Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Child Trichuris trichiura infection prevalence	Up to 24 months	Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Child diarrhea prevalence	Up to 24 months	Prevalence of diarrhea is defined as 3 or more loose or watery stools in 24 hours or 1 or more stools with blood in 24 hours at any follow-up measurement. Diarrhea will be based on caregiver-reported symptoms in the birth cohort with 2-day and 7-day recall at any follow-up measurement through month 24
Child development	12, 24 months	Mean Z-score using the Ages and Stages Questionnaire Inventory (ASQi) overall and within 5 domains: communication skills, gross motor skills, fine motor skills, problem solving skills, and personal social skills.; Z-scores will be calculated for each domain that are standardized by age in days to the control group. Z-scores \> 0 indicate child development attainment above the median for children of the same age in the control arm. Z-scores \< 0 indicate child development attainment below the median for children of the same age in the control arm.
Child stimulation	12, 24 months	Mean scores for child stimulating activities, child stimulating play materials and caregiver responsiveness and child environment will be calculated separately using the Family Care Indicators tool at ages 12 and 24 months.
Child length-for-age Z-score	Birth and 3, 6, 12, 18, 24 months	Length or height will be measured at birth, and 3, 6, 12, 18, and 24 months follow-up. Length-for-age z-scores (LAZ) will be calculated using the World Health Organization's 2006 Child Growth Standards.; LAZ \< -2 standard distributions below the median is defined as moderately stunted, and LAZ \< -3 standard distributions below the median is defined as severely stunted.
Child weight-for-length Z-score	Birth and 3, 6, 12, 18, 24 months	Weight and length or height will be measured at birth, and 3, 6, 12, 18, and 24 months follow-up. Weight-for-length z-scores (WLZ) will be calculated using the World Health Organization's 2006 Child Growth Standards.; WLZ \< -2 standard distributions below the median is defined as moderately wasted, and WLZ \< -3 standard distributions below the median is defined as severely wasted.
Child weight-for-age Z-score	Birth and 3, 6, 12, 18, 24 months	Weight will be measured at birth, and 3, 6, 12, 18, and 24 months follow-up. Weight-for-age z-scores (WAZ) will be calculated using the World Health Organization's 2006 Child Growth Standards.; WAZ \< -2 standard distributions below the median is defined as moderately underweight, and WAZ \< -3 standard distributions below the median is defined as severely underweight.
Within-sample diversity of child gut microbial communities	Up to 24 months	Alpha diversity index for microbes, as determined by bioinformatic analysis of shotgun metagenomic sequencing data for a subsample of child stool samples (6, 12, 18, 24 months follow-up)
Between-sample diversity of child gut microbial communities	Up to 24 months	Beta diversity index for microbes, as determined by bioinformatic analysis of shotgun metagenomic sequencing data for a subsample of child stool samples (6, 12, 18, 24 months follow-up)
Child antimicrobial resistance genes	Up to 24 months	Antimicrobial resistance genes detected in a subsample of child stool samples using shotgun metagenomic sequencing (6, 12, 18, 24 months)
Maternal satisfaction with quality of life	3, 12, 24 months	Percentage of mothers very satisfied or satisfied with their quality of life at 3, 12, 24 months follow-up and the percentage of mothers with an improvement in their reported quality of life between baseline and each follow-up (3, 12, 24 months).
Maternal stress	3, 12 months	Mean Perceived Stress Scale score for mothers. The scale ranges from 0-40, and higher scores indicate higher perceived stress. Scores from 0-13 will be classified as mild stress, 14-26 as moderate stress, and 27-40 as severe stress.
Maternal depression	Baseline, 3, 12 months	Prevalence of maternal depression based on a score of 11 or higher and mean total score using the Edinburgh Postnatal Depression Scale measured at the 6 month follow-up visit. The scale ranges from 0-30, and higher scores indicate presence of more depression symptoms.
Maternal non-verbal reasoning	6, 18 months	Mean maternal Raven's Progressive Matrices score (range: 0-60) and percentile. Higher scores indicate higher non-verbal reasoning.
Maternal visual-spatial working memory	6, 18 months	Mean highest level completed of Corsi Block Span task (range: 1-10). Higher scores indicate higher visual-spatial working memory.
Maternal cognitive inhibition	6, 18 months	Percentage of correct responses and response time in the Hearts and Flowers task. Higher percentages and shorter response times indicate higher cognitive inhibition.
Maternal cognitive flexibility and attention shifting	6, 18 months	Percentage of correct responses and response time in the Dimensional Change Card Sort test. Higher percentages and shorter response times indicate higher cognitive flexibility and attention shifting.
Maternal daily discretionary time	6, 18 months	Maternal hours of discretionary time per week measured using hybrid time diaries and activity lists
Ascaris lumbricoides prevalence in household floor samples	Up to 24 months	Prevalence of Ascaris lumbricoides in household floor dust detected with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Necator americanus prevalence in household floor samples	Up to 24 months	Prevalence of Necator americanus detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Trichuris trichiura prevalence in household floor samples	Up to 24 months	Prevalence of Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Any soil-transmitted helminth prevalence in household floor samples	Up to 24 months	Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura detected in household floor dust with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Larvated Ascaris lumbricoides prevalence in household floor samples	Up to 24 months	Prevalence of larvated Ascaris lumbricoides detected by microscopy in household floor swabs at any follow-up measurement (6, 12, 18, 24 months)
Larvated Trichuris trichiura prevalence in household floor samples	Up to 24 months	Prevalence of larvated Trichuris trichiura detected by microscopy in household floor swabs at any follow-up measurement (6, 12, 18, 24 months)
Culturable E. coli abundance in household floor samples	Up to 24 months	Abundance (most probable number per square meter) of E. coli in household floor swabs detected with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Culturable E. coli abundance in child hand rinse samples	Up to 24 months	Abundance (most probable number per two hands) of E. coli on child hands enumerated with IDEXX in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Culturable cefotaxime-resistant E. coli prevalence in household floor samples	Up to 24 months	Prevalence of cefotaxime-resistant E. coli in household floor swabs detected with a modified IDEXX protocol with cefotaxime supplement in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up)
Culturable extended spectrum beta-lactamase (ESBL) producing E. coli prevalence in household samples	6 months	Prevalence of ESBL-producing E. coli in child stool, floor swabs, courtyard soil, hand rinses, drinking water, food, chicken feces, and cow feces
Frequency of child soil contact	Up to 24 months	Mean number of child soil contact events per hour measured using video observations in a sub-sample of the birth cohort at any follow-up measurement (6, 12, 18, 24 months follow-up)
Frequency of child soil ingestion	Up to 24 months	Mean number of child soil ingestion events per hour measured using video observations in a sub-sample of the birth cohort at any follow-up measurement (6, 12, 18, 24 months follow-up)
Within-sample diversity of environmental samples	6 months	Alpha diversity index for microbes, as determined by bioinformatic analysis of shotgun metagenomic sequencing data for a subsample of floor soil, cow feces and chicken feces samples.
ESBL-coding genes in household samples	6 months	Prevalence of ESBL-coding genes detected using PCR in child stool, floor swabs, courtyard soil, hand rinses, drinking water, food, chicken feces, and cow feces
Between-sample diversity of environmental samples	6 months	Beta diversity index for microbes, as determined by bioinformatic analysis of shotgun metagenomic sequencing data for a subsample of floor soil, cow feces and chicken feces samples.
Antimicrobial resistance genes in environmental samples	6 months	Antimicrobial resistance genes detected in a subsample of floor soil, cow feces and chicken feces samples using shotgun metagenomic sequencing.
Mass of floor dust	Up to 24 months	Mass of dust on floors collected by sweeping a 2 m2 floor area next to bed where child sleeps at night (6, 12, 18, 24 months)

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh