Dataset Information

IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study.

ABSTRACT:

Background

Respiratory syncytial virus (RSV) is the most common cause of acute lower respiratory tract infection in infants. Globally, RSV is responsible for approximately 3.2 million hospital admissions and about 60,000 in-hospital deaths per year.

Methods

Infection with RespIratory Syncytial Virus (IRIS) is an observational, multi-centre study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age between 0 and 36 months and hospitalisation due to RSV infection at three German sites. Exclusion criteria are premature birth, congenital or acquired bronchopulmonary or cardiac diseases, and immunodeficiency. Healthy control probands are enrolled via recruitment of patients undergoing routine surgical procedures. Blood and respiratory specimens are collected upon admission, and RSV and other pathogens are analysed by multiplex polymerase chain reaction. Different biomaterials, including plasma, nasal lining fluid, blood cells, DNA, and RNA specimens, are sampled in a dedicated biobank. Detailed information on demographic characteristics and medical history is recorded, and comprehensive clinical data, including vital signs, medication, and interventions.

Discussion

The IRIS study aims to discover host and viral factors controlling RSV disease courses in infants. The approach including multi-omics characterisation in clinically well-characterized children with RSV bronchiolitis seeks to improve our understanding of the immune response against this virus. It may disclose novel diagnostic and treatment approaches for respiratory infections in infants.

Trial registration

ClinicalTrials.gov, NCT04925310. Registered 01 October 2021-Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04925310?cond=NCT04925310&draw=2&rank=1.

SUBMITTER: Wetzke M

PROVIDER: S-EPMC8922907 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study.

Wetzke Martin M Funken Dominik D Lange Mathias M Bejo Levente L Haid Sibylle S Monteiro Joao G Tereno JGT Schütz Katharina K Happle Christine C Schulz Thomas F TF Seidenberg Jürgen J Pietschmann Thomas T Hansen Gesine G

BMC pulmonary medicine 20220315 1

<h4>Background</h4>Respiratory syncytial virus (RSV) is the most common cause of acute lower respiratory tract infection in infants. Globally, RSV is responsible for approximately 3.2 million hospital admissions and about 60,000 in-hospital deaths per year.<h4>Methods</h4>Infection with RespIratory Syncytial Virus (IRIS) is an observational, multi-centre study enrolling infants with severe RSV infection and healthy controls. Inclusion criteria are age between 0 and 36 months and hospitalisation ...[more]

PMID: 35291998

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Project description:BackgroundRespiratory 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.MethodsWe 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.FindingsIn 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).InterpretationRSV-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.FundingInnovative 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.

Project description:Abstract Background Pneumococcal conjugate vaccines (PCV) reduced the risk of respiratory syncytial virus (RSV) in a randomized clinical trial. We aimed to assess the real-world effectiveness of PCV on RSV-hospitalizations among Western Australian infants. Methods We conducted a population-based cohort study of births during 2000–2012, using probabilistically linked individual-level immunization, hospitalization, respiratory microbiology testing, and perinatal data. We performed Cox proportional hazard models with time-varying exposure (receipt of infant PCV doses) against the first RSV-confirmed hospitalization 0–12 months adjusted for perinatal and sociodemographic factors. Results From 360 994 children, 3-dose PCV coverage in Aboriginal infants ranged from 29% to 51% in 2001–2004 when PCV was funded for Aboriginal children only. Following universal funding in 2005, coverage increased to 85% for Aboriginal and 73% for non-Aboriginal infants. RSV-hospitalization rates were highest in young infants aged 0–5 months (22.5/1000 child-years) and >2 times higher in Aboriginal infants than in non-Aboriginal infants. Receipt of ≥3 PCV doses in the universal funded period was associated with a 30% reduction in RSV-hospitalization in Aboriginal infants (adjusted hazard ratio, aHR 0.70 [95% confidence interval, CI 0.46–1.06]) and 21% reduction in non-Aboriginal infants (aHR 0.79 [95% CI 0.63–0.99]) compared with unvaccinated infants. Conclusions Prior to the introduction of RSV vaccines, our study suggests that universal childhood PCV vaccination may result in a reduction in severe RSV infections in children and may be important for countries that are yet to consider PCV programs. Through population-based linked data analysis, we show a real-world protective benefit of pneumococcal conjugate vaccines (PCV) on respiratory syncytial virus (RSV) hospitalizations in infants. These findings are relevant for settings with a high RSV burden but no current universal PCV program.

Project description:BackgroundRespiratory Syncytial Virus (RSV) infections may lead to severe consequences in infants born preterm with breathing problems (such as bronchopulmonary dysplasia (BPD) and respiratory distress syndrome (RDS)) or congenital heart diseases (CHD). Since studies investigating the influence of different gestational age (WGA) and concomitant specific comorbidities on the burden of RSV infections are scarce, the present study aimed to better characterize these high-risk populations in the Italian context.MethodsThis retrospective, longitudinal and record-linkage cohort study involved infants born between 2017 and 2019 in Lazio Region (Italy) and is based on data extracted from administrative databases. Each infant was exclusively included in one of the following cohorts: (1) BPD-RDS (WGA ≤35 with or without CHD) or (2) CHD (without BPD and/or RDS) or (3) Preterm (WGA ≤35 without BPD (and/or RDS) or CHD). Each cohort was followed for 12 months from birth. Information related to sociodemographic at birth, and RSV and Undetermined Respiratory Agents (URA) hospitalizations and drug consumption at follow-up were retrieved and described.ResultsA total of 8,196 infants were selected and classified as 1,084 BPD-RDS, 3,286 CHD and 3,826 Preterm. More than 30% of the BPD-RDS cohort was composed by early preterm infants (WGA ≤ 29) in contrast to the Preterm cohort predominantly constitute by moderate preterm infants (98.2%), while CHD infants were primarily born at term (83.9%). At follow-up, despite the cohorts showed similar proportions of RSV hospitalizations, in BPD-RDS cohort hospitalizations were more frequently severe compared to those occurred in the Preterm cohort (p<0.01), in the BPD-RDS cohort was also found the highest proportion of URA hospitalizations (p<0.0001). In addition, BPD-RDS infants, compared to those of the remaining cohorts, received more frequently prophylaxis with palivizumab (p<0.0001) and were more frequently treated with adrenergics inhalants, and glucocorticoids for systemic use.ConclusionsThe assessment of the study clinical outcomes highlighted that, the demographic and clinical characteristics at birth of the study cohorts influence their level of vulnerability to RSV and URA infections. As such, continuous monitoring of these populations is necessary in order to ensure a timely organization of health care system able to respond to their needs in the future.

Dataset Information

IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study.

Background

Methods

Discussion

Trial registration

Publications

IRIS: Infection with RespIratory Syncytial Virus in infants-a prospective observational cohort study.

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