Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial
Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial
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DOI：
10.1289/ehp5751
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发表时间：
2020-04-01
影响因子：
10.4
通讯作者：
Clark, Maggie L.
中科院分区：
文献类型：
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作者：
Barr, Dana Boyd;Puttaswamy, Naveen;Clark, Maggie L.
背景：暴露、易感性和影响的生物标志物是理解环境暴露、影响的机制途径和监测早期不良后果的基础。迄今为止，还没有一项研究综合评估了家庭空气污染（HAP）研究中与暴露和结果数据相一致的大量生物标志物。家庭空气污染干预网络（HAPIN）试验是一项液化石油气（LPG）燃料/炉灶随机干预试验，在四个国家（即秘鲁、危地马拉、卢旺达和印度）分别招募了800名孕妇。将对它们的后代进行从出生到12个月大的随访，以评估出生前后从对照组的生物质燃烧炉灶和干预组的液化石油气炉灶中暴露于HAP对生长和呼吸结果的作用。此外，每个站点在同一家庭中招募了多达200名老年成年妇女，以评估心肺、代谢和癌症结局的指标。目的：在这里，我们描述了一个综合生物标志物计划的基本原理和最终设计，使我们能够更充分地探索暴露与疾病结果的关系。方法：HAPIN入组和数据收集始于2018年5月，并将持续到2021年8月。作为数据收集的一部分，孕妇和老年妇女在怀孕期间将采集三次干血斑（DBS）和尿液样本。DBS是在孩子出生时收集的。老年妇女和儿童的脑起搏器和尿液样本在儿童出生后的第一年被采集了三次。将在所有参与者中纵向测量的暴露生物标志物包括尿中羟基多环芳烃、挥发性有机化学代谢物、金属/类金属、左旋葡聚糖和可替宁。将分析老年女性尿液、DBS或血液制品中的生物标志物，包括炎症、内皮和氧化应激生物标志物、肺癌标志物和其他临床相关指标。同样，将在老年成年妇女样本中测量基因组/表观遗传标记、微生物组和代谢组学。讨论：我们的研究设计将产生丰富的生物标志物数据，以非常详细地评估暴露与健康结果之间的联系。此外，我们的设计是全面和创新的，包括代谢组学和表观遗传学等前沿措施。
BACKGROUND: Biomarkers of exposure, susceptibility, and effect are fundamental for understanding environmental exposures, mechanistic pathways of effect, and monitoring early adverse outcomes. To date, no study has comprehensively evaluated a large suite and variety of biomarkers in household air pollution (HAP) studies in concert with exposure and outcome data. The Household Air Pollution Intervention Network (HAPIN) trial is a liquified petroleum gas (LPG) fuel/stove randomized intervention trial enrolling 800 pregnant women in each of four countries (i.e., Peru, Guatemala, Rwanda, and India). Their offspring will be followed from birth through 12 months of age to evaluate the role of pie- and postnatal exposure to HAP from biomass burning cookstoves in the control arm and LPG stoves in the intervention arm on growth and respiratory outcomes. In addition, up to 200 older adult women per site are being recruited in the same households to evaluate indicators of cardiopulmonary, metabolic, and cancer outcomes.OBJECTIVES: Here we describe the rationale and ultimate design of a comprehensive biomarker plan to enable us to explore more fully how exposure is related to disease outcome.METHODS: HAPIN enrollment and data collection began in May 2018 and will continue through August 2021. As a part of data collection, dried blood spot (DBS) and urine samples are being collected three times during pregnancy in pregnant women and older adult women. DBS are collected at birth for the child. DBS and urine samples are being collected from the older adult women and children three times throughout the child's first year of life. Exposure biomarkers that will be longitudinally measured in all participants include urinary hydroxy-polycyclic aromatic hydrocarbons, volatile organic chemical metabolites, metals/metalloids, levoglucosan, and cotinine. Biomarkers of effect, including inflammation, endothelial and oxidative stress biomarkers, lung cancer markers, and other clinically relevant measures will be analyzed in urine, DBS, or blood products from the older adult women. Similarly, genomic/epigenetic markers, microbiome, and metabolomics will be measured in older adult women samples.DISCUSSION: Our study design will yield a wealth of biomarker data to evaluate, in great detail, the link between exposures and health outcomes. In addition, our design is comprehensive and innovative by including cutting-edge measures such as metabolomics and epigenetics.