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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-5
SponsorEskisehir Osmangazi University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Parent or legal guardian declines consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

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.
2

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.

Time frame
During the index hospitalization, from hospital admission to hospital discharge, up to 24 hours.
3

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.

Time frame
From hospital admission to hospital discharge during the index hospitalization, up to 24 hours.

Secondary outcomes

1

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.

Time frame
Index ED visit (from ED arrival/registration or triage to ED disposition and ED departure), up to 24 hours.
2

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).

Time frame
From ED arrival to hospital discharge, up to 24 hours.
3

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.

Time frame
From ED arrival/registration (or triage) through hospital discharge for the index episode of care, up to 24 hours.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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