NL-OMON52425招募中不适用
REspiratory Syncytial virus Consortium in EUrope (RESCEU): Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae. - Understanding RSV: Severe disease and the long term consequences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •Parent/carer of infant is willing and able to give informed consent for
- •participation in the study.
- •Male or female, and less than 12 months of age at enrolment.
- •Parent has a telephone.
- •Hospitalized for <48 hours at enrolment or within 96hrs of onset of illness
- •(for those not admitted).*
- •Live near enough to a participating study centre for the 6-8 week home
- •visit/hospital appointment to be feasible.*, * not applicable for healthy
- •control infants (group 2)
- •Inclusion criteria - Extension until 6 years of age
- •- Participants from Group 1a (previously healthy infants hopsitalized with RSV)
- •and Group 1b (previously healthy with RSV infection that did not require
- •admission).
- •- Informed consent obtained from parents
排除标准
- •History of concurrent clinically significant medical illness (not directly
- •attributable to RSV infection) including but not limited to, cardiovascular,
- •respiratory, renal, gastrointestinal, haematology, neurology, endocrinology,
- •immunology, musculoskeletal, oncological or congenital disorders, as judged by
- •the investigator*
- •Specifically excluded examples include, but are not limited to:
- •o Immunosuppressed states
- •o Bronchopulmonary dysplasia/chronic lung disease of infancy
- •o Congenital heart disease
- •o Down*s syndrome
- •Prematurity, as defined as gestational age <37 weeks at birth.*
- •History of receipt of medication to treat RSV infection (e.g. ribavirin).
- •Prior exposure to an RSV investigational vaccine or medication.
- •History of receipt of immunoglobulin or monoclonal antibodies (including
- •palivizumab).
- •Use of steroids or montelukast within 7 days of enrolment in the study.
- •Parents not able to communicate in the local language or English.
- •* Inclusion criteria (and/or) for exploratory group of RSV infected infants
- •with comorbidity (group 1c and 1d)
- •Exclusion criteria - Extension study until 6 years of age:
研究者
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