Use of Biomass Briquettes: Its Effect on Indoor Air Pollution and on Pneumococcal Nasopharyngeal Carriage. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- IAP Carriage Study
研究概览
简要总结
Personal exposure to Indoor Air Pollution (IAP) is a known risk factor of severe pneumonia, which is the number one killer of children under five in developing countries. The main source of IAP in developing countries is cooking fires, with an estimated 3 billion people still reliant on biomass stoves for their daily cooking. This study will test the effectiveness of an intervention aimed to reduce IAP, as well as help to quantify the relationship between exposure (IAP) and infection (pneumococcal carriage).
In Phase I (adjunct pilot study L2010.99), 3 fuels and 5 stoves were tested to measure harmful pollutant emissions. The preliminary results showed that the largest difference was found in the fuels (briquettes cleaner than wood), with a smaller difference found between a couple of the improved stoves and the traditional 3-stone. Re-testing of selected stove/fuel combinations to confirm findings has just been completed. Phase II (this proposal) will test the biomass briquettes in a randomized clinical trial to measure actual IAP reductions in households. A proof of concept pneumococcal survey will also be conducted as a secondary study to see whether reduced exposure to IAP affects pneumococcal carriage in babies and mothers
详细描述
Acute respiratory infections (ARI), specifically Severe Pneumonia, are the leading cause of death in children under 5 years of age. Of the nearly 10 million children under 5 who die each year, 1.9 million die from ARI, almost all of which occur in developing countries [1, 2]. Over the years, various studies have identified many risk factors associated with ARI, including malnutrition, zinc deficiency, indoor air pollution (IAP) from solid fuels and tobacco. Proven efficacious interventions have been developed and studied to address risk factors related to nutrition and zinc deficiency but still little is known about IAP and proven effective interventions. Furthermore, little is known about the quantifiable relationship between IAP exposure and disease, specifically ARI.
IAP from cooking with biomass is one of the top ten global health risks [3]. 1.6 million people are estimated to die every year from IAP exposure, of which half of them are children under 5 years of age [4]. In developing countries, IAP is estimated to account for 3.7% of the total burden of disease, making it the fourth most serious health risk factor after malnutrition, STDs, and inadequate water and sanitation [5]. A recent meta-analysis found that children under 5 years old living in households using biomass fuels had a 78% greater chance of contracting pneumonia than did children in households with cleaner-burning fuels [6]. In Africa, 94% of the rural population and 73% of the urban population use solid fuels as their primary source of energy [7]. Not only does IAP disproportionally affect the poor, but it also affects women and children who spend more time near the cooking fires and are therefore are most exposed.
Because of the difficulty in measuring exposure, most observational studies use proxy measures. These proxies include the type of fuel used, amount of time spent near the cooking fires, or whether the child is carried on the mother's back during cooking. But because variations in personal exposure in most countries depend on a variety of factors (e.g. fuel, stove, housing, behavioral), proxy indicators are an insufficient method to effectively capture variations in exposure [8]. This affects the understanding and knowledge of the potential health gains that might result from reducing exposure by varying amounts. Determining this exposure-disease relationship is crucial to understanding the possible impacts that interventions may have on improving health [9]. Unfortunately, the amount of research being done on pollutant exposure from IAP is negligible compared to the huge disease burden associated with this exposure [10]. A lot more research needs to be conducted to help the lives of the 3 billion affected from these harmful pollutants.
Interventional Research Interventional research has focused on developing more efficient biomass stoves as an approach to reduce IAP, yet few studies have looked into alternative biomass fuels. Though improved stoves have shown to reduce pollutant emissions in controlled settings, it remains difficult to measure the true effectiveness of this intervention, i.e. whether these stoves are actually reducing pollutants in local kitchens. The Water Boiling Test (WBT) and Controlled Cooking Tests (CCT), both of which are conducted in controlled environments, are based on the assumption that performing a simple cooking task produces estimates that can be used when evaluating technology for developing populations [11]. However, because of the numerous behavioral and outside variables that can alter the efficiency of a stove, these tests do not illustrate the true picture of how the technology will perform among the population [12]. The Kitchen Performance Test (KPT) has been designed to measure the effectiveness though because of its difficulties in implementation, it is often not used to measure stove performance. Furthermore, there have been varying results in the field effectiveness of reducing IAP with improved stoves [9]. Given the wide variability in stoves and settings, it remains difficult to know what levels of IAP exposure reductions can be expected.
Because of the uncertainties and challenges of reducing IAP with improved stoves, other interventions to reduce pollutant levels need to be explored, such as the use of alternative biomass fuel in lieu of wood. A study in 2003 in rural Kenya looked at modelling potential reductions on disease following interventions including fuel, stove type and cooking location. This study showed that the largest reduction was from switching fuels and not stoves [3]. There are a handful of studies throughout developing countries that are currently looking at using crop waste as an alternative fuel. But because crop waste varies greatly with locality, separate testing needs be done on these different crop wastes and their transformation into cooking fuel. In The Gambia and most of West and Central Africa, groundnuts are a major cash crop and their shells are available in abundance. Recently, two separate factories have been established in The Gambia to process these dried groundnut shells into biomass briquettes, which will then be used as cooking fuel. During Phase I of this study, the investigators have tested (and are currently retesting) the two available biomass briquettes made from groundnut shells. Both the WBT and CCT are being conducted to evaluate the performance of these fuels (in comparison to wood and charcoal) when used with different stoves, as well as IAP emissions. These tests were conducted in accordance with the protocol developed for the Shell Foundation and Household Energy Health Program [13, 14]. The investigators also concurrently measured PM2.5 concentrations two ways: continuous PM2.5 concentrations using light-scattering, TSI 8520 DustTrak monitors and integrated PM2.5 concentrations using gravimetric Casella pumps, cyclones, and Teflon filters. CO concentrations were also measured alongside the CCT using Drager CO 50/a-D Diffusion Tubes. The Investigators preliminary analysis shows that the briquettes do burn much cleaner than wood when used with each of the tested stoves. The investigators are currently retesting the briquettes with the different stoves to assure the investigators have the cleanest stove/fuel combination for Phase II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Months 至 8 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child between 2 to 8 months of age at start of the study (1st pneumococcal swab)
- •residing within the catchment area
- •the mother relies only on wood and the 3-stone stove for all her cooking
- •the mother will cook in an indoor kitchen only (not outside; 4 walls with a roof)
- •written informed consent
排除标准
- •will be traveling from their home during the following 6 months
- •already involved in another study
研究组 & 干预措施
cooking with Biomass Briquettes and Rocket Stove
cooking with Biomass Briquettes and Rocket Stove
干预措施: Biomass Briquettes and Rocket stove (Device)
standard cooking
standard way of cooking
结局指标
主要结局
IAP Carriage Study
时间窗: 12 months
1. Integrated PM2.5 concentrations (48 hour measurements in each kitchen) Integrated PM2.5 concentrations will be measured using gravimetric Casella and SKC pumps, cyclones, and Teflon filters. The pumps will run one minute on, 5 minutes off, for 48 continuous hours in each of the participating cookhouses. These integrated measurements will allow us to compare the emissions from briquettes and firewood. The measurements will take place at a random time during the 16 week invention period
次要结局
- IAP Carriage Study(12 months)
