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

NCT07346963 | Not Yet Recruiting

• 2 other identifiers: TRUST-RSV-v0012025-16
• Study Type: observational
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Bronchiolitis Due to Respiratory Syncytial Virus; Pneumonia; Upper Respiratory Tract Infection; Respiratory Syncytial Virus Infection

Keywords

pediatric emergency department; multicenter; prospective; healthcare utilization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

Eligibility Criteria

• Age: 28 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Parent or legal guardian declines consent

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Related Publications (2)

• 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 RESULT

• 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.2023-065623.

  PMID: 38841769 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Pneumonia; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Emre Güngör, M.D.

CONTACT

+905064255240; emre.gungor@ogu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emre Güngör, MD (Assistant Professor) , Principal Investigator

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share