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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Respiratory Syncytial Virus Infection; Upper Respiratory Tract Infection; Acute Bronchiolitis Due to Respiratory Syncytial Virus

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Emre Güngör, M.D.; Phone Number: +905064255240; Email: emre.gungor@ogu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged <5 years presenting to participating pediatric emergency departments in Türkiye during consecutive RSV season (2025-2026 ) who have respiratory syncytial virus (RSV) infection confirmed from a nasopharyngeal specimen using rapid antigen testing and/or PCR according to local site capacity and standard clinical practice. Eligible participants include RSV-positive children evaluated for compatible clinical diagnoses at presentation (e.g., upper respiratory tract infection, bronchiolitis, pneumonia, apnea, seizure/convulsion, or myocarditis). Enrollment requires written informed consent from a parent or legal guardian; children are excluded only if consent is declined. Clinical management is not assigned by the protocol and follows routine care; participants are observed for outcomes during the index emergency department encounter and, when applicable, through the index hospitalization.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization rate	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.	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	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.	During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.
Need for respiratory support among RSV-positive children	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.	From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED length of stay (ED observation duration) among RSV-positive children	Time from ED arrival/registration (or triage time, per site practice) to ED disposition, defined as discharge home or departure from the ED for inpatient admission. Duration will be reported in hours.	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	Presence of pre-specified complications documented during the index ED visit and/or hospitalization (e.g., apnea requiring intervention, seizure/convulsion, myocarditis, suspected bacterial co-infection, or other clinically documented complications).	From ED arrival to hospital discharge, up to 24 hours.
Diagnostic evaluations performed during the index visit	Proportion of participants who undergo any diagnostic evaluation during the index visit as documented in the medical record and recorded in the study database. Diagnostic evaluations include, but are not limited to, chest radiography and laboratory testing performed in accordance with the standard of care.	From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Publications and helpful links

General Publications

• Tan L. A clinical observation on therapeutic effects of acupuncture for allergic rhinitis. J Tradit Chin Med. 1999 Jun;19(2):129-31. No abstract available.
• Conti CR. Evolution of NCEP guidelines: ATP1-ATPIII risk estimation for coronary heart disease in 2002. National Cholesterol Education Program. Clin Cardiol. 2002 Mar;25(3):89-90. doi: 10.1002/clc.4960250302. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prospective; multicenter; healthcare utilization; pediatric emergency department
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumonia; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: TRUST-RSV-v001; 2025-16 (Eskisehir Osmangazi University Scientific Research Projects Unit)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study was not designed with an IPD-sharing plan in place, and the current ethics approvals and informed consent documents do not include provisions for public IPD sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No