Cement flooRs AnD chiLd hEalth (CRADLE)

NCT ID: NCT05372068

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-24

Study Completion Date

2026-09-30

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.

Detailed Description

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Conditions

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Ascaris Lumbricoides Infection Necator Americanus Infection Trichuris Trichiura; Infection Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Concrete household floor

Group Type EXPERIMENTAL

Concrete household floor

Intervention Type OTHER

Household soil floors will be replaced with concrete floors

Non-intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Concrete household floor

Household soil floors will be replaced with concrete floors

Intervention Type OTHER

Eligibility Criteria

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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

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

North Carolina State University

OTHER

Sponsor Role collaborator

Soil Transmitted Helminthiasis Control Program, Directorate General of Health Services, Bangladesh

UNKNOWN

Sponsor Role collaborator

Stanford Woods Institute for the Environment

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jade Benjamin-Chung

Assistant Professor of Epidemiology & Population Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jade Benjamin-Chung, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain MS, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health: the CRADLE trial - a randomised controlled trial protocol. BMJ Open. 2025 Mar 3;15(3):e090703. doi: 10.1136/bmjopen-2024-090703.

Reference Type DERIVED
PMID: 40032381 (View on PubMed)

Rahman M, Jahan F, Hanif S, Yeamin A, Shoab AK, Andrews JR, Lu Y, Billington S, Pilotte N, Shanta IS, Jubair M, Rahman M, Kabir M, Haque R, Tofail F, Hossain S, Mahmud ZH, Ercumen A, Benjamin-Chung J. Effects of household concrete floors on maternal and child health - the CRADLE trial: a randomised controlled trial protocol. medRxiv [Preprint]. 2024 Jul 27:2024.07.26.24311076. doi: 10.1101/2024.07.26.24311076.

Reference Type DERIVED
PMID: 39108529 (View on PubMed)

Other Identifiers

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R01HD108196

Identifier Type: NIH

Identifier Source: secondary_id

View Link

63990

Identifier Type: -

Identifier Source: org_study_id

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