Cement flooRs AnD chiLd hEalth (CRADLE)

Study Overview
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Brief Summary
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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.

Official Title
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Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh

Conditions
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Diarrhea, Necator Americanus Infection, Ascaris Lumbricoides Infection, Trichuris Trichiura; Infection

Intervention / Treatment
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* Other: Concrete household floor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residence in Chauhali upazila, Sirajganj district 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 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concrete household floor<br> | Other: Concrete household floor<br>* Household soil floors will be replaced with concrete floors<br>|
| No Intervention: Non-intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child prevalence of any soil-transmitted helminth infection | 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 | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Ascaris lumbricoides infection prevalence | Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up | Up to 24 months | 
| Child Necator americanus infection prevalence | Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up | Up to 24 months | 
| Child Trichuris trichiura infection prevalence | Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up | Up to 24 months | 
| Child diarrhea prevalence | 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 | Up to 24 months | 
| Child prevalence of other enteric pathogen carriage | Prevalence of other enteric pathogens in stool samples detected using a TaqMan array card in a sub-sample of the birth cohort | 12 months | 
| Child development | 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. | 12, 24 months | 
| Child stimulation | 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. | 12, 24 months | 
| Child length-for-age Z-score | 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. | Birth and 3, 6, 12, 18, 24 months | 
| Child weight-for-length Z-score | 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. | Birth and 3, 6, 12, 18, 24 months | 
| Child weight-for-age Z-score | 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. | Birth and 3, 6, 12, 18, 24 months | 
| Maternal satisfaction with quality of life | 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). | 3, 12, 24 months | 
| Maternal stress | 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. | 3, 12 months | 
| Maternal depression | 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. | Baseline, 3, 12 months | 
| Maternal non-verbal reasoning | Mean maternal Raven's Progressive Matrices score (range: 0-60) and percentile. Higher scores indicate higher non-verbal reasoning. | 6, 18 months | 
| Maternal visual-spatial working memory | Mean highest level completed of Corsi Block Span task (range: 1-10). Higher scores indicate higher visual-spatial working memory. | 6, 18 months | 
| Maternal daily discretionary time | Maternal hours of discretionary time per week measured using hybrid time diaries and activity lists | 6, 18 months | 
| Ascaris lumbricoides prevalence in household floor samples | Prevalence of Ascaris lumbricoides in household floor swabs detected with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up) | Up to 24 months | 
| Necator americanus prevalence in household floor samples | Prevalence of Necator americanus detected in household floor swabs with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up) | Up to 24 months | 
| Trichuris trichiura prevalence in household floor samples | Prevalence of Trichuris trichiura detected in household floor swabs with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up) | Up to 24 months | 
| Any soil-transmitted helminth prevalence in household floor samples | Prevalence of Ascaris lumbricoides, Necator americanus, or Trichuris trichiura detected in household floor swabs with qPCR in a sub-sample of households at any follow-up measurement (6, 12, 18, 24 months follow-up) | Up to 24 months | 
| Culturable E. coli abundance in household floor samples | 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) | Up to 24 months | 
| Culturable E. coli abundance in child hand rinse samples | 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) | Up to 24 months | 
| Enteric pathogen carriage in household floor samples | Prevalence of other enteric pathogens in household floor samples detected using a TaqMan array card in a sub-sample of households | 12 months | 
| Frequency of child soil contact | 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) | Up to 24 months | 
| Frequency of child soil ingestion | 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) | Up to 24 months |