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Набор скоро начнётся NCT07620613

Perinatal Mortality Outcomes Through Household Infection Pathways

Без фазы С лечением Stillbirth and Neonatal Mortality Perinatal Mortality Infant Mortality Child Mortality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Concrete household floor.
Кому может быть актуально
Состояния в реестре: Stillbirth and Neonatal Mortality, Perinatal Mortality, Infant Mortality, Child Mortality. Базовые параметры: до 6 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Bangladesh
Следующий шаг
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Официальное название

Effect of Cement Floors on Perinatal and Neonatal Mortality in Bangladesh: a Randomized Trial in Rural Bangladesh

Обзор

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.

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

  • Extended perinatal mortality rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]
Вторичные конечные точки (5)
  • Stillbirth rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]
  • Early neonatal mortality rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]
  • Neonatal mortality rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]
  • Infant mortality rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]
  • Child mortality rate [Срок оценки: Up to 6 years post-intervention delivery in parent study]

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Bangladesh · 1 центр
  • International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka

Публикации

  • 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 PMID 39108529

Идентификаторы

NCT: NCT07620613 · 86289 · 03001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗