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Design and Rationale of the Biomarker Center of the Household Air Pollution Intervention Network (HAPIN) Trial.
Environmental Health Perspectives ( IF 10.4 ) Pub Date : 2020-04-29 , DOI: 10.1289/ehp5751 Dana Boyd Barr 1 , Naveen Puttaswamy 2 , Lindsay M Jaacks 3 , Kyle Steenland 1 , Sarah Rajkumar 2 , Savannah Gupton 1 , P Barry Ryan 1 , Kalpana Balakrishnan 2 , Jennifer L Peel 4 , William Checkley 5, 6 , Thomas Clasen 1 , Maggie L Clark 4 ,
Environmental Health Perspectives ( IF 10.4 ) Pub Date : 2020-04-29 , DOI: 10.1289/ehp5751 Dana Boyd Barr 1 , Naveen Puttaswamy 2 , Lindsay M Jaacks 3 , Kyle Steenland 1 , Sarah Rajkumar 2 , Savannah Gupton 1 , P Barry Ryan 1 , Kalpana Balakrishnan 2 , Jennifer L Peel 4 , William Checkley 5, 6 , Thomas Clasen 1 , Maggie L Clark 4 ,
Affiliation
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 pre- 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. https://doi.org/10.1289/EHP5751.
中文翻译:
家庭空气污染干预网络(HAPIN)试验生物标志物中心的设计和原理。
背景技术暴露,易感性和作用的生物标志物对于理解环境暴露,作用的机理途径以及监测早期不良后果至关重要。迄今为止,尚无研究结合暴露和结果数据全面评估家庭空气污染(HAP)研究中的一大套生物标志物。家庭空气污染干预网络(HAPIN)试验是液化石油气(LPG)燃料/炉子随机干预试验,在四个国家(秘鲁,危地马拉,卢旺达和印度)的每个国家招募了800名孕妇。他们的后代将从出生到12个月不等,以评估出生前和产后暴露于HAP的作用,这些作用来自控制臂中燃烧生物质的炊具和干预臂中LPG炉灶对生长和呼吸结果的影响。此外,在同一家庭中,每个站点最多招募200名成年女性,以评估心肺,代谢和癌症结局的指标。目的在这里,我们描述了全面的生物标志物计划的原理和最终设计,以使我们能够更全面地探索暴露与疾病结局的关系。方法HAPIN登记和数据收集始于2018年5月,并将持续到2021年8月。作为数据收集的一部分,孕妇和成年孕妇在怀孕期间三次收集了干血斑(DBS)和尿液样本。DBS是在孩子出生时收集的。在儿童出生后的第一年,他们从成年人和儿童中抽取了3次DBS和尿液样本。将在所有参与者中进行纵向测量的接触生物标志物包括尿羟基多环芳烃,挥发性有机化学代谢产物,金属/准金属,左旋葡聚糖和可替宁。作用的生物标志物,包括炎症,内皮和氧化应激生物标志物,肺癌标志物以及其他临床相关措施,将在成年女性的尿液,DBS或血液制品中进行分析。同样,将在成年女性样本中测量基因组/表观遗传学标记,微生物组和代谢组学。讨论我们的研究设计将产生大量的生物标志物数据,以更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,包括了代谢组学和表观遗传学等前沿技术。https://doi.org/10。
更新日期:2020-04-29
中文翻译:
家庭空气污染干预网络(HAPIN)试验生物标志物中心的设计和原理。
背景技术暴露,易感性和作用的生物标志物对于理解环境暴露,作用的机理途径以及监测早期不良后果至关重要。迄今为止,尚无研究结合暴露和结果数据全面评估家庭空气污染(HAP)研究中的一大套生物标志物。家庭空气污染干预网络(HAPIN)试验是液化石油气(LPG)燃料/炉子随机干预试验,在四个国家(秘鲁,危地马拉,卢旺达和印度)的每个国家招募了800名孕妇。他们的后代将从出生到12个月不等,以评估出生前和产后暴露于HAP的作用,这些作用来自控制臂中燃烧生物质的炊具和干预臂中LPG炉灶对生长和呼吸结果的影响。此外,在同一家庭中,每个站点最多招募200名成年女性,以评估心肺,代谢和癌症结局的指标。目的在这里,我们描述了全面的生物标志物计划的原理和最终设计,以使我们能够更全面地探索暴露与疾病结局的关系。方法HAPIN登记和数据收集始于2018年5月,并将持续到2021年8月。作为数据收集的一部分,孕妇和成年孕妇在怀孕期间三次收集了干血斑(DBS)和尿液样本。DBS是在孩子出生时收集的。在儿童出生后的第一年,他们从成年人和儿童中抽取了3次DBS和尿液样本。将在所有参与者中进行纵向测量的接触生物标志物包括尿羟基多环芳烃,挥发性有机化学代谢产物,金属/准金属,左旋葡聚糖和可替宁。作用的生物标志物,包括炎症,内皮和氧化应激生物标志物,肺癌标志物以及其他临床相关措施,将在成年女性的尿液,DBS或血液制品中进行分析。同样,将在成年女性样本中测量基因组/表观遗传学标记,微生物组和代谢组学。讨论我们的研究设计将产生大量的生物标志物数据,以更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,包括了代谢组学和表观遗传学等前沿技术。https://doi.org/10。