Evaluation of Demographic, Clinical, and Healthcare Utilization Characteristics of Respiratory Syncytial Virus (RSV) Positive Cases Under 5 Years Presenting to Pediatric Emergency Departments in Türkiye: A Multicenter, Prospective Observational Study (TRUST-RSV)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 主要终点
- Hospitalization rate
研究概览
简要总结
Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory tract infection in infants and young children and contributes substantially to pediatric emergency department (ED) visits and hospitalizations. In Türkiye, nationally representative prospective data describing the epidemiology, clinical spectrum, and resource utilization of RSV-positive children presenting to pediatric EDs remain limited. This multicenter prospective observational study aims to characterize demographic and clinical features of RSV-positive children under 5 years of age presenting to participating pediatric EDs across two consecutive RSV seasons, and to quantify key healthcare utilization outcomes, including ED observation duration, hospitalization, and intensive care unit (ICU) admission.
详细描述
This is a multicenter, prospective observational cohort study conducted in pediatric emergency departments in Türkiye over a consecutive RSV season. Eligible participants are children younger than 5 years who present to a participating pediatric ED with at least one compatible clinical diagnosis and have RSV infection confirmed by a nasopharyngeal sample using either a rapid antigen test or PCR, based on local site capacity. Written informed consent will be obtained from a parent or legal guardian prior to study procedures.
Standardized case report forms will be used to collect demographics (age, sex, region, socioeconomic indicators), relevant risk factors (e.g., prematurity, congenital heart disease, chronic lung disease, passive smoke exposure, breastfeeding status), presenting symptoms, vital signs and physical examination findings, diagnostic evaluations (radiology and laboratory results as available), and clinical management and outcomes. Outcomes of interest include ED observation duration, disposition (discharge vs hospitalization), ICU admission, and, when applicable, the need for oxygen or ventilatory support. Data will be entered into a secure centralized database. The study will evaluate seasonal and regional patterns and will explore predictors of severe outcomes among RSV-positive children using multivariable models.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age <5 years at presentation
- •Presentation during RSV season (2025-2026 )
- •RSV infection confirmed from a nasopharyngeal sample by rapid antigen test or PCR according to site capacity
- •Presentation to a participating pediatric ED with at least one of the following clinical diagnoses: upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis
- •Written informed consent obtained from a parent or legal guardian.
排除标准
- •Parent or legal guardian declines consent
结局指标
主要结局
Hospitalization rate
时间窗: Index ED visit (from ED presentation/triage to ED disposition decision and departure from the ED for inpatient admission or discharge), up to 24 hours.
Proportion of children with laboratory-confirmed RSV infection presenting to participating pediatric EDs who are hospitalized from the index ED encounter. "Hospitalized" is defined as admission from the ED to an inpatient unit (ward) or intensive care unit (ICU) immediately following ED evaluation; children discharged home are classified as not hospitalized.
ICU admission rate among hospitalized RSV-positive children
时间窗: During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.
Proportion of hospitalized children with laboratory-confirmed RSV infection who require admission to an intensive care unit (ICU) at any time during the index hospitalization. ICU admission is defined as transfer from the ED or inpatient ward to an ICU for higher-level monitoring and/or organ support.
Need for respiratory support among RSV-positive children
时间窗: From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.
Proportion of RSV-positive children who receive any respiratory support documented in the medical record, including supplemental oxygen (any delivery method) and/or noninvasive ventilation (e.g., HFNC/CPAP/BiPAP per local practice) and/or invasive mechanical ventilation.
次要结局
- ED length of stay (ED observation duration) among RSV-positive children(Index ED visit (from ED arrival/registration or triage to ED disposition and ED departure), up to 24 hours.)
- Occurrence of RSV-associated complications during the index visit(From ED arrival to hospital discharge, up to 24 hours.)
- Diagnostic evaluations performed during the index visit(From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.)
研究者
Emre Güngör
Emre Güngör, MD (Assistant Professor) , Principal Investigator
Eskisehir Osmangazi University