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Perinatal Mortality Outcomes Through Household Infection Pathways (POTH)

27. maj 2026 opdateret af: Jade Benjamin-Chung, Stanford University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

196

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh
        • Ledende efterforsker:
          • Md. Mahbubur Rahman, MBBS

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 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 plan to relocate within the study follow-up period
  • Incident pregnancy occurring after CRADLE trial enrollment, confirmed at 13-30 weeks gestation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Ikke-intervention
Eksperimentel: Concrete household floor
Household soil floors will be replaced with concrete floors
Andet: Beton husstandsgulv
Husstandsjordgulve udskiftes med betongulve

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Extended perinatal mortality rate
Tidsramme: 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)
Up to 6 years post-intervention delivery in parent study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stillbirth rate
Tidsramme: 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) divided by the number of total births (live births + stillbirths)
Up to 6 years post-intervention delivery in parent study
Early neonatal mortality rate
Tidsramme: Up to 6 years post-intervention delivery in parent study
Total number of deaths occurring in the first 7 days of life divided by the number of live births
Up to 6 years post-intervention delivery in parent study
Neonatal mortality rate
Tidsramme: Up to 6 years post-intervention delivery in parent study
Total number of deaths occurring in the first 28 days of life divided by the number of live births
Up to 6 years post-intervention delivery in parent study
Infant mortality rate
Tidsramme: Up to 6 years post-intervention delivery in parent study
Total deaths prior to age 12 months among live births divided by total live births
Up to 6 years post-intervention delivery in parent study
Child mortality rate
Tidsramme: Up to 6 years post-intervention delivery in parent study
Total deaths at any age among live births divided by total live births
Up to 6 years post-intervention delivery in parent study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Samarbejdspartnere

International Centre for Diarrhoeal Disease Research, Bangladesh
Thrasher Research Fund
North Carolina State University
Directorate General of Health Services, Bangladesh

Efterforskere

  • Ledende efterforsker: Jade Benjamin-Chung, PhD MPH, Stanford University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2029

Studieafslutning (Anslået)

1. maj 2029

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 86289
  • 03001 (Andet bevillings-/finansieringsnummer: Thrasher Foundation)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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).

IPD-delingstidsramme

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-delingsadgangskriterier

To be determined

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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