RSV-Positive Children <5 Years Presenting to Pediatric Emergency Departments in Türkiye: TRUST-RSV

Official title

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)

Overview

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.

Detailed description

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.

Primary outcome measures

• Hospitalization rate [Time frame: 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.]
• ICU admission rate among hospitalized RSV-positive children [Time frame: During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.]
• Need for respiratory support among RSV-positive children [Time frame: From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.]

Secondary outcome measures (3)

• ED length of stay (ED observation duration) among RSV-positive children [Time frame: 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 [Time frame: From ED arrival to hospital discharge, up to 24 hours.]
• Diagnostic evaluations performed during the index visit [Time frame: From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Parent or legal guardian declines consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, Johannesen CK, Fernandez LV, Teirlinck AC, Wang X, Heikkinen T, Bangert M, Caini S, Campbell H, Paget J; RESCEU Investigators. Burden of Respiratory Syncytial Virus in the European Union: estimation of RSV-associated hospitalizations in children under 5 years. J Infect Dis. 2023 Nov 28;228(11):1528-1538. doi: 10.1093/infdis/jiad188. PMID 37246724
• McMorrow ML, Moline HL, Toepfer AP, Halasa NB, Schuster JE, Staat MA, Williams JV, Klein EJ, Weinberg GA, Clopper BR, Boom JA, Stewart LS, Selvarangan R, Schlaudecker EP, Michaels MG, Englund JA, Albertin CS, Mahon BE, Hall AJ, Sahni LC, Curns AT. Respiratory Syncytial Virus-Associated Hospitalizations in Children <5 Years: 2016-2022. Pediatrics. 2024 Jul 1;154(1):e2023065623. doi: 10.1542/peds.20 PMID 38841769

Identifiers

NCT: NCT07346963 · TRUST-RSV-v001 · 2025-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗