Objectives, design and enrollment results from the Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE)
Objectives, design and enrollment results from the Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure Study (INSPIRE)
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DOI：
10.1186/s12890-015-0040-0
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发表时间：
2015-04-30
影响因子：
3.1
通讯作者：
Hartert, Tina V.
中科院分区：
文献类型：
--
作者：
Larkin, Emma K.;Gebretsadik, Tebeb;Hartert, Tina V.
背景：婴儿期呼吸道合胞病毒（RSV）下呼吸道感染（LRI）一直与儿童哮喘风险增加相关。此外，有证据表明这种关系是因果关系。然而，RSV 导致哮喘发展的机制尚不清楚。 INSPIRE（婴儿接触 RSV 后肺部感染和哮喘的易感性）研究目标是：1) 表征婴儿期对 RSV 感染的宿主表型反应以及复发性喘息和哮喘的风险，2) 确定与儿童早期喘息疾病和哮喘发展相关的 RSV 感染的免疫反应和肺损伤模式，以及 3) 确定特定 RSV 毒株对儿童早期的影响喘息和哮喘的发展。本文介绍了 INSPIRE 研究，包括研究目的、设计、招募结果和入组人群特征。方法/设计：该队列是一个基于人群的纵向出生队列，以足月健康婴儿为基础，在两年的时间里在生命的头几个月内入组。呼吸道感染监测是在出生后第一年的 11 月至 3 月期间进行的，每两周进行一次调查。如果婴儿符合预先指定的呼吸道疾病就诊标准，则进行面对面的疾病就诊。每年对 3-4 岁的婴儿进行随访，以评估主要终点：喘息疾病。在整个研究过程中的不同时间点收集鼻腔、尿液、粪便和血液样本，以测量预测喘息疾病的宿主和病毒因素。巢式病例对照研究还将用于解决其他主要和次要假设。讨论：在 INSPIRE 研究中，在两个入组年份中入组了 1952 名婴儿（48% 为女性），随访将持续到 2016 年。平均入组年龄为 60 天。在冬季病毒流行季节，开展了超过 14,000 次监测调查，对 1189 名婴儿进行了 2,103 次呼吸道疾病就诊。自入组第一年起，超过 95% 的参与者已完成第一年随访。通过对喘息和儿童哮喘结果的持续随访，INSPIRE 研究将增进我们对 RSV 感染与幼儿喘息和哮喘之间复杂因果关系的理解。
Background: Respiratory syncytial virus (RSV) lower respiratory tract infection (LRI) during infancy has been consistently associated with an increased risk of childhood asthma. In addition, evidence supports that this relationship is causal. However, the mechanisms through which RSV contributes to asthma development are not understood. The INSPIRE (Infant Susceptibility to Pulmonary Infections and Asthma Following RSV Exposure) study objectives are to: 1) characterize the host phenotypic response to RSV infection in infancy and the risk of recurrent wheeze and asthma, 2) identify the immune response and lung injury patterns of RSV infection that are associated with the development of early childhood wheezing illness and asthma, and 3) determine the contribution of specific RSV strains to early childhood wheezing and asthma development. This article describes the INSPIRE study, including study aims, design, recruitment results, and enrolled population characteristics.Methods/design: The cohort is a population based longitudinal birth cohort of term healthy infants enrolled during the first months of life over a two year period. Respiratory infection surveillance was conducted from November to March of the first year of life, through surveys administered every two weeks. In-person illness visits were conducted if infants met pre-specified criteria for a respiratory illness visit. Infants will be followed annually to ages 3-4 years for assessment of the primary endpoint: wheezing illness. Nasal, urine, stool and blood samples were collected at various time points throughout the study for measurements of host and viral factors that predict wheezing illness. Nested case-control studies will additionally be used to address other primary and secondary hypotheses.Discussion: In the INSPIRE study, 1952 infants (48% female) were enrolled during the two enrollment years and follow-up will continue through 2016. The mean age of enrollment was 60 days. During winter viral season, more than 14,000 surveillance surveys were carried out resulting in 2,103 respiratory illness visits on 1189 infants. First year follow-up has been completed on over 95% percent of participants from the first year of enrollment.With ongoing follow-up for wheezing and childhood asthma outcomes, the INSPIRE study will advance our understanding of the complex causal relationship between RSV infection and early childhood wheezing and asthma.