An observational study in Respiratory Syncytial Virus Infection, Acute Bronchiolitis Due to Respiratory Syncytial Virus and Pneumonia, sponsored by Eskisehir Osmangazi University. Not yet recruiting. Open to participants aged 28 Days to 5 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Eskisehir Osmangazi University · Observational
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.
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.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 346 across 73 observational studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
No study locations are listed for this record.
Plan to share: No — 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.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Eskisehir Osmangazi University