Cement flooRs AnD chiLd hEalth (CRADLE)
Primary Purpose
Ascaris Lumbricoides Infection, Necator Americanus Infection, Trichuris Trichiura; Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Concrete household floor
Sponsored by
About this trial
This is an interventional prevention trial for Ascaris Lumbricoides Infection
Eligibility Criteria
Inclusion Criteria:
- Residence in Comilla district in Bangladesh
- No plan to relocate in the next 2 years
- Reside in home with floors made entirely of soil
- Pregnant women in her second or third trimester resides in the home at the time of enrollment
Exclusion Criteria:
- Home is not strictly residential (e.g., includes a business)
Sites / Locations
- International Centre for Diarrhoeal Disease Research, Bangladesh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Concrete household floor
Non-intervention
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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.
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.
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.
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.
Maternal satisfaction with quality of life
Percentage of mothers satisfied or very satisfied with their quality of life based on a five-point scale (very satisfied, satisfied, neither satisfied nor unsatisfied, somewhat unsatisfied, unsatisfied)
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.
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.
Maternal non-verbal reasoning
Mean maternal Raven's Progressive Matrices score (range: 0-60) and percentile. Higher scores indicate higher non-verbal reasoning.
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.
Maternal daily discretionary time
Maternal hours of discretionary time per week measured using hybrid time diaries and activity lists
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)
Necator americanus 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)
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)
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)
Culturable E. coli prevalence 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)
Culturable E. coli prevalence and 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)
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
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)
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)
Full Information
NCT ID
NCT05372068
First Posted
May 6, 2022
Last Updated
September 1, 2023
Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Soil Transmitted Helminthiasis Control Program, Directorate General of Health Services, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT05372068
Brief Title
Cement flooRs AnD chiLd hEalth (CRADLE)
Official Title
Cement flooRs AnD chiLd hEalth (CRADLE): a Randomized Trial in Rural Bangladesh
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Soil Transmitted Helminthiasis Control Program, Directorate General of Health Services, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascaris Lumbricoides Infection, Necator Americanus Infection, Trichuris Trichiura; Infection, Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concrete household floor
Arm Type
Experimental
Arm Title
Non-intervention
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Concrete household floor
Intervention Description
Household soil floors will be replaced with concrete floors
Primary Outcome Measure Information:
Title
Child prevalence of any soil-transmitted helminth infection
Description
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
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Child Ascaris lumbricoides infection prevalence
Description
Prevalence of Ascaris lumbricoides infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Time Frame
Up to 24 months
Title
Child Necator americanus infection prevalence
Description
Prevalence of Necator americanus infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Time Frame
Up to 24 months
Title
Child Trichuris trichiura infection prevalence
Description
Prevalence of Trichuris trichiura infection in birth cohort detected with qPCR at 6, 12, 18, or 24 months follow-up
Time Frame
Up to 24 months
Title
Child diarrhea prevalence
Description
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
Time Frame
Up to 24 months
Title
Child prevalence of other enteric pathogen carriage
Description
Prevalence of other enteric pathogens in stool samples detected using a TaqMan array card in a sub-sample of the birth cohort
Time Frame
12 months
Title
Child development
Description
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.
Time Frame
12, 24 months
Title
Child length-for-age Z-score
Description
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.
Time Frame
Birth and 3, 6, 12, 18, 24 months
Title
Child weight-for-length Z-score
Description
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.
Time Frame
Birth and 3, 6, 12, 18, 24 months
Title
Child weight-for-age Z-score
Description
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.
Time Frame
Birth and 3, 6, 12, 18, 24 months
Title
Maternal satisfaction with quality of life
Description
Percentage of mothers satisfied or very satisfied with their quality of life based on a five-point scale (very satisfied, satisfied, neither satisfied nor unsatisfied, somewhat unsatisfied, unsatisfied)
Time Frame
Baseline, 3, 12, 24 months
Title
Maternal stress
Description
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.
Time Frame
3, 12 months
Title
Maternal depression
Description
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.
Time Frame
Baseline, 3, 12 months
Title
Maternal non-verbal reasoning
Description
Mean maternal Raven's Progressive Matrices score (range: 0-60) and percentile. Higher scores indicate higher non-verbal reasoning.
Time Frame
6, 18 months
Title
Maternal visual-spatial working memory
Description
Mean highest level completed of Corsi Block Span task (range: 1-10). Higher scores indicate higher visual-spatial working memory.
Time Frame
6, 18 months
Title
Maternal daily discretionary time
Description
Maternal hours of discretionary time per week measured using hybrid time diaries and activity lists
Time Frame
6, 18 months
Title
Ascaris lumbricoides prevalence in household floor samples
Description
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)
Time Frame
Up to 24 months
Title
Necator americanus in household floor samples
Description
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)
Time Frame
Up to 24 months
Title
Trichuris trichiura prevalence in household floor samples
Description
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)
Time Frame
Up to 24 months
Title
Any soil-transmitted helminth prevalence in household floor samples
Description
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)
Time Frame
Up to 24 months
Title
Culturable E. coli prevalence in household floor samples
Description
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)
Time Frame
Up to 24 months
Title
Culturable E. coli prevalence and abundance in child hand rinse samples
Description
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)
Time Frame
Up to 24 months
Title
Enteric pathogen carriage in household floor samples
Description
Prevalence of other enteric pathogens in household floor samples detected using a TaqMan array card in a sub-sample of households
Time Frame
12 months
Title
Frequency of child soil contact
Description
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)
Time Frame
Up to 24 months
Title
Frequency of child soil ingestion
Description
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)
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jade Benjamin-Chung, PhD MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Centre for Diarrhoeal Disease Research, Bangladesh
City
Dhaka
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahbubur Rahman
First Name & Middle Initial & Last Name & Degree
Mahbubur Rahman, MBBS, MPH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All human subjects and environmental data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. Coded data from videos will be made public, but videos will not be published in order to protect participant privacy. All data will be made available at the individual level (or household level, in the case of the household survey).
IPD Sharing Time Frame
De-identified data will be made publicly available within 2 years of the end of the study or at the time of publication, whichever is sooner.
IPD Sharing Access Criteria
To be determined
Learn more about this trial
Cement flooRs AnD chiLd hEalth (CRADLE)
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