An observational study in Fever, Triage and Pediatric Emergency Medicine, sponsored by TC Erciyes University. Recruiting at 10 sites in Turkey (Türkiye). Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by TC Erciyes University · Observational
This multicenter prospective observational cohort study evaluates how well the initial triage category assigned by the Turkish Ministry of Health three-level color-coded triage system (Red-Yellow-Green) predicts serious clinical outcomes in children aged 0-18 years who present with fever to pediatric emergency departments. The study additionally assesses whether physiological parameters recorded at triage (heart rate, respiratory rate, oxygen saturation, capillary refill time, AVPU level of consciousness, and general appearance) provide independent and incremental prognostic value beyond the assigned triage category. Ten centers across Turkey will enroll consecutive eligible febrile children over a 3-month period. Routine clinical care and triage decisions are not altered by the study. The primary outcome is a composite serious clinical outcome. The study is reported in accordance with the STROBE and TRIPOD statements.
Design: Prospective, multicenter, observational cohort study. Setting: 10 pediatric emergency departments in Turkey; Erciyes University is the coordinating center. Population: consecutive children aged 0-18 years presenting with fever (>=38.0 C at triage or history of fever within the preceding 24 hours). Trauma presentations, elective visits, records with missing triage data, and re-attendances within 72 hours for the same episode are excluded (only the first visit is included). Physiological parameters are recorded on a standardized triage form and are NOT used to change the triage decision. Heart rate is modeled as a continuous variable with age-based z-scores (Fleming reference ranges), with body temperature always included as a covariate to distinguish fever-related from pathological tachycardia. Sample size: assuming a serious-outcome (composite) event rate of \~3%, approximately 3000 children (\~90 events) are targeted (\~300 per center over 3 months), following Riley et al. (BMJ 2020) criteria (target R2>=0.15, calibration slope>=0.90) in addition to the EPV>=10 rule. A pilot evaluation at the end of the first month recalculates the true event rate. Analysis: Triage performance is summarized with sensitivity, specificity, PPV, NPV, LR+ and LR- with 95% CIs. A pre-specified 3-step mixed-effects logistic regression (centers as random effect) compares Model 1 (triage category only), Model 2 (+ physiological parameters and temperature), and Model 3 (+ laboratory variables in the tested subgroup). Discrimination (ROC/AUC, DeLong test, NRI, IDI) and calibration (calibration curve and slope, O/E ratio) are reported. Missing data are handled by multiple imputation (m=20).
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 408 across 140 observational studies indexed under Fever.
Browse Fever studies →TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children aged 0-18 years presenting with fever (\>=38.0 C at triage or history of fever within the preceding 24 hours) to a participating pediatric emergency department during the 3-month study period. All undergo routine triage with the Ministry of Health three-level color-coded system; triage decisions and clinical care are not altered by the study.
Diagnostic Test: Ministry of Health three-level color-coded triage
At presentation, each child is assigned a triage category (Red, Yellow, or Green) by the triage nurse using the Turkish Ministry of Health three-level color-coded system, and physiological parameters (heart rate, respiratory rate, oxygen saturation, capillary refill time, AVPU level of consciousness, and general appearance) are recorded on a standardized triage form. This reflects routine care and is not modified for the study.
Composite serious clinical outcome
Presence of at least one of: intensive care unit admission; invasive or non-invasive mechanical ventilation; vasopressor/inotropic therapy; culture- or sterile-body-fluid-confirmed invasive bacterial infection; 30-day mortality.
Time frame: 30 Dys
Hospital admission with intravenous antibiotics
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
Time frame: Up to 30 days
Sepsis protocol activation
Activation of an institutional sepsis protocol during the index emergency department visit.
Time frame: Index ED visit (day 1)
Intravenous fluid bolus of at least 20 mL/kg
Administration of an intravenous fluid bolus of at least 20 mL/kg during the index emergency department visit.
Time frame: Index ED visit (day 1)
Unplanned re-attendance with admission
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
Time frame: 72 hours
All-cause hospital ward admission
Admission to a hospital ward for any cause.
Time frame: Index ED visit (day 1)
Undertriage rate
Proportion of Green-triaged patients who develop the primary composite outcome.
Time frame: 30 days
Overtriage rate
Proportion of Red-triaged patients who do not develop the primary composite outcome.
Time frame: 30 days
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available from the coordinating center on reasonable request, subject to approval by the coordinating ethics committee and a data-sharing agreement, in accordance with institutional and national data-protection regulations.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 3 months after the start.
Of 51 non-industry observational studies under Fever, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 3 months is below that.
Counting every sponsor, half of 61 studies reached it within 22 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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