Cement flooRs AnD chiLd hEalth (CRADLE)

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372068
• Other study ID #: 63990
• Secondary ID: R01HD108196
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrhea
• Infections
• Necator Americanus Infection
• Trichuriasis
• Trichuris Trichiura; Infection

Intervention

Other:
• Concrete household floor
Household soil floors will be replaced with concrete floors

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	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

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maternal daily discretionary time	Maternal hours of discretionary time per week measured using hybrid time diaries and activity lists	6, 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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