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

NCT ID: NCT07346963

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-06-01

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Emre Güngör

Emre Güngör, MD (Assistant Professor) , Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Emre Güngör, M.D.

Role: CONTACT

emre.gungor@ogu.edu.tr

+905064255240

References

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.

Reference Type: RESULT

PMID: 10681872 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11890375 (View on PubMed)

Other Identifiers

2025-16

Identifier Type: OTHER

Identifier Source: secondary_id

TRUST-RSV-v001

Identifier Type: -

Identifier Source: org_study_id