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临床试验/NCT00786877
NCT00786877已完成3 期

Cookstove Replacement for Prevention of ALRI and Low Birthweight in Nepal

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 4,678 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
4,678
试验地点
1
主要终点
Incidence of acute lower respiratory illness.

研究概览

简要总结

At our field site in southern Nepal, acute respiratory illness (ARI) has been a leading cause of mortality among young children. Besides immunization there is little evidence for effective primary preventive approaches for ARI on a population basis. Low birth weight is highly prevalent in this population as well affecting approximately 30% of live born infants. Low birth weight is a key determinant of neonatal mortality and has also been resistant to cost-effective interventions in resource poor settings. Given the lack of appropriate interventions for poor, rural areas in developing countries and the strong observational association between open burning of biomass fuel sources and ARI in young children and low birth weight, we have designed a community-based randomized trial to determine if reductions in household indoor smoke exposure can reduce the incidence and duration of acute lower respiratory infections in children <36 months of age and low birthweight among newborn infants. Household indoor smoke reduction will be accomplished by replacing the current cook stove in the household with a locally appropriate, inexpensive model that is more efficient and vented to the exterior. In addition, we will assess the impact on respiratory function and symptoms among adults in the household. The project has 2 phases. Phase 1 is a cluster-randomized, community-based, step-wedge trial of cookstove replacement in a rural population of southern Nepal. Households will be randomized to receive replacement of their cook stove with an appropriately designed, efficient stove that is vented to the exterior at different time periods during the course of the study. An initial period of surveillance for ARI and low birth weight will establish a baseline rate for all clusters. This will be followed by the randomized, serial replacements of cook stoves over a 12 month period. Surveillance will continue throughout this period and for an additional 6 -18 months depending on when the stove was replaced. Phase 2 is a individually randomized trial in a subset of households that will receive either the improved biomass stove from phase 1 or a LPG stove and gas. Follow-up for phase 2 will be for 12 months with the same outcomes as phase 1. Measurement of indoor air particulate concentration will be conducted in all households before and after stove replacement. The analysis for both phases will focus on estimating the impact on incidence of ARI in children and low birth weight among live births as a result of stove replacement. Approximately 4200 children 1-35 months of age will be required to observe a minimum 10% reduction in risk of ARI with 90% power in phase 1. Given the expected number of live births to occur in these clusters, we can detect a 50 gram difference in birthweight with over 90% power and a type I error of 5%. Phase 2 will have lower power (total of 1800 households).

详细描述

See brief summary above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • All households with traditional open burning cookstoves in the study area.

排除标准

  • Houses with walls of thatch or bamboo
  • Inclusion criteria:
  • households in the phase 1 study area that either participated in phase 1 or are newly eligible household since phase 1 began. Eligible households are those with either a resident married pregnant woman or at least one child less than 24 months of age.

结局指标

主要结局

Incidence of acute lower respiratory illness.

时间窗: <36 months of age

Incidence of Low Birthweight

时间窗: All live births

次要结局

  • Incidence of pre-term birth(all live births)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James M. Tielsch

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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