Stillbirth and Neonatal MortalityPOTHNCT07620613
Perinatal Mortality Outcomes Through Household Infection Pathways
A study testing Concrete household floor in people with Stillbirth and Neonatal Mortality and Perinatal Mortality, run by Stanford University at 1 site in Bangladesh.
Trial summary
The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Stillbirth and Neonatal Mortality, Perinatal Mortality, Infant Mortality
- What is being tested?
- Concrete household floor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household
- Residence in Sirajganj or Tangail districts in Bangladesh
- No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)
- No plan to relocate within the study follow-up period
- Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
Md. Mahbubur Rahman, MBBS
About this study
Official title: Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh
The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?
Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.
This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.
Read the detailed description
This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).
- Being tested
- Concrete household floor
- Keywords
- concrete floor, soil floor, dirt floor, housing intervention
- Medical subject headings
- Stillbirth, Perinatal Death, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concrete household floorOther
Household soil floors will be replaced with concrete floors
| Study group | Role | What they receive |
|---|---|---|
| Concrete household floor | Experimental | Household soil floors will be replaced with concrete floors Receives: Other: Concrete household floor |
| Non-intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extended perinatal mortality rate
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) and neonatal deaths within the first 28 days after birth divided by the number of total births (live births + stillbirths)
Measured: Up to 6 years post-intervention delivery in parent study
Secondary outcomes (5)
Stillbirth rate
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) divided by the number of total births (live births + stillbirths)
Measured: Up to 6 years post-intervention delivery in parent study
Early neonatal mortality rate
Total number of deaths occurring in the first 7 days of life divided by the number of live births
Measured: Up to 6 years post-intervention delivery in parent study
Neonatal mortality rate
Total number of deaths occurring in the first 28 days of life divided by the number of live births
Measured: Up to 6 years post-intervention delivery in parent study
Infant mortality rate
Total deaths prior to age 12 months among live births divided by total live births
Measured: Up to 6 years post-intervention delivery in parent study
Child mortality rate
Total deaths at any age among live births divided by total live births
Measured: Up to 6 years post-intervention delivery in parent study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stillbirth and Neonatal MortalityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Directorate General of Health Services, Bangladesh
- Responsible party
- Principal investigator, Jade Benjamin-Chung, Stanford University
- Investigators
- Jade Benjamin-Chung, PhD MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620613
- Sponsor's protocol ID
- 86289
- Other IDs
- 03001
- Acronym
- POTH
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All human subjects data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. All data will be made available at the individual level (outcomes, covariates) or household level (in the case of the household survey variables, i.e. wealth).
Publications
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.
PubMed 39108529
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT07620613
- Acronym / sponsor ID
- POTH / 86289
- Keywords
- concrete floor, soil floor, dirt floor, housing intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Directorate General of Health Services, Bangladesh
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors?
Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention.
This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.
Detailed description
This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concrete household floor | Experimental | Other: Concrete household floorHousehold soil floors will be replaced with concrete floors |
| Non-intervention | No intervention | – |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household
- Residence in Sirajganj or Tangail districts in Bangladesh
- No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)
- No plan to relocate within the study follow-up period
- Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concrete household floorHousehold soil floors will be replaced with concrete floors | Other | Concrete household floor |
Primary outcome
Extended perinatal mortality rate
Time frame: Up to 6 years post-intervention delivery in parent study
Total number of stillbirths (babies born following fetal deaths at 22 weeks or later gestation) and neonatal deaths within the first 28 days after birth divided by the number of total births (live births + stillbirths)
5 secondary outcomes
Stillbirth rate
Time frame: Up to 6 years post-intervention delivery in parent study
Early neonatal mortality rate
Time frame: Up to 6 years post-intervention delivery in parent study
Neonatal mortality rate
Time frame: Up to 6 years post-intervention delivery in parent study
Infant mortality rate
Time frame: Up to 6 years post-intervention delivery in parent study
Child mortality rate
Time frame: Up to 6 years post-intervention delivery in parent study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 39108529Rahman 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.
- Parent trial Clinicaltrials.gov registrationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All human subjects data will be de-identified and published. Identifiers that will be removed include participant names, address, date of birth, and geocoordinates. All data will be made available at the individual level (outcomes, covariates) or household level (in the case of the household survey variables, i.e. wealth).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jade Benjamin-Chung, PhD MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concrete household floor in people with Stillbirth and Neonatal Mortality and Perinatal Mortality, run by Stanford University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended perinatal mortality rate (time frame: Up to 6 years post-intervention delivery in parent study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07620613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.