Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07346963

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Respiratory Syncytial Virus Infection Acute Bronchiolitis Due to Respiratory Syncytial Virus Infections Lung Diseases Mononegavirales Infections Paramyxoviridae Infections Pneumonia Pneumovirus Infections RNA Virus Infections Respiratory Syncytial Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Upper Respiratory Tract Infection Virus Diseases

Age range

28 day–5 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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.

  2. ICU admission rate among hospitalized RSV-positive children

    Time frame: 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.

  3. Need for respiratory support among RSV-positive children

    Time frame: 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.

Secondary outcomes

  1. 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.

    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.

  2. Occurrence of RSV-associated complications during the index visit

    Time frame: From ED arrival to hospital discharge, up to 24 hours.

    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).

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emre Güngör, M.D.

CONTACT

[email protected]

+905064255240

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study 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)

Acronym: TRUST-RSV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.