The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study.
The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study.
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DOI：
10.1016/s2213-2600(22)00414-3
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发表时间：
2023-04
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呼吸道合胞病毒(RSV)是导致婴儿住院的主要原因。健康足月婴儿感染RSV的负担尚未确定。当RSV疫苗可用时，健康婴儿的准确保健负担数据对于确定RSV免疫接种政策是必要的。我们对位于不同欧洲国家的五个地点的健康足月儿(孕期37周)进行了一项多中心、前瞻性、观察性出生队列研究，以确定≥的医疗负担。出生第一年RSV相关住院的发生率通过父母问卷和医院病历回顾来确定。我们在嵌套队列中进行了积极的呼吸道合胞病毒监测，以确定医疗人员参与的呼吸道合胞病毒感染的发生率。这项研究注册在ClinicalTrials.gov，NCT03627572。总共有9154名在2017年7月1日至2020年4月1日期间出生的婴儿在第一年期间接受了跟踪调查，其中993人参加了嵌套的积极监测队列。RSV相关住院率为1.8%(95%可信区间1·6-2·1)。共有8个儿科重症监护病房入院，占145例呼吸道合胞病毒相关住院患者的5.5%，占总队列的0.09%。在任何诊断方法确认的积极监测队列中，RSV感染的发生率为26.2%(24.0~28.6)，有医疗参与的RSV感染发生率为14.1%(12.3~16.0)。呼吸道合胞病毒相关的急性呼吸道感染导致大量发病率，导致在高收入环境中每56名健康足月出生婴儿中就有一名住院。孕妇或健康的足月儿在第一个冬季接种疫苗可能会对RSV感染造成的卫生保健负担产生重大影响。创新药物倡议2联合开展，得到欧盟地平线2020研究和创新方案和欧洲制药业和协会联合会的支持。
Respiratory syncytial virus (RSV) is a major cause of hospitalisation in infants. The burden of RSV infection in healthy term infants has not yet been established. Accurate health-care burden data in healthy infants are necessary to determine RSV immunisation policy when RSV immunisation becomes available. We performed a multicentre, prospective, observational birth cohort study in healthy term-born infants (≥37 weeks of gestation) in five sites located in different European countries to determine the health-care burden of RSV. The incidence of RSV-associated hospitalisations in the first year of life was determined by parental questionnaires and hospital chart reviews. We performed active RSV surveillance in a nested cohort to determine the incidence of medically attended RSV infections. The study is registered with ClinicalTrials.gov, NCT03627572. In total, 9154 infants born between July 1, 2017, and April 1, 2020, were followed up during the first year of life and 993 participated in the nested active surveillance cohort. The incidence of RSV-associated hospitalisations in the total cohort was 1·8% (95% CI 1·6–2·1). There were eight paediatric intensive care unit admissions, corresponding to 5·5% of 145 RSV-associated hospitalisations and 0·09% of the total cohort. Incidence of RSV infection in the active surveillance cohort confirmed by any diagnostic assay was 26·2% (24·0–28·6) and that of medically attended RSV infection was 14·1% (12·3–16·0). RSV-associated acute respiratory infection causes substantial morbidity, leading to the hospitalisation of one in every 56 healthy term-born infants in high-income settings. Immunisation of pregnant women or healthy term-born infants during their first winter season could have a major effect on the health-care burden caused by RSV infections. Innovative Medicines Initiative 2 Joint Undertaking, with support from the EU's Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations.