Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department (PEDTRIAGE)

Triage Performance and Physiological Parameters Predicting Serious Illness in Children Presenting With Fever to the Pediatric Emergency Department: A Multicenter Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Fever; Triage; Serious Bacterial Infection; Pediatric Emergency Medicine
• Intervention / Treatment: Diagnostic test: Ministry of Health three-level color-coded triage

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Yilmaz Secilmis, MD; Phone Number: +905063013174; Email: yilmazsecilmis@erciyes.edu.tr

Study Locations

• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Adana City Training and Research Hospital
    • Contact: Saadetnur Bozgeyik Aksoy, MD; Phone Number: +90 05077185767; Email: saadetnb@gmail.com
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Cukurova University Faculty of Medicine
    • Contact: Sevcan Bilen, MD; Phone Number: +90 532 276 50 84; Email: svcnbln@hotmail.com
  • Antalya, Turkey (Türkiye)
    • Recruiting
    • Akdeniz University Faculty of Medicine
    • Contact: Ozlem Tolu Kendir, MD; Phone Number: +90 505 304 98 09; Email: otolu80@yahoo.com
  • Eskişehir, Turkey (Türkiye)
    • Recruiting
    • Osmangazi University Faculty of Medicine
    • Contact: Emre Gungor, MD; Phone Number: +90 506 425 52 40; Email: emregungormd@gmail.com
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Kartal Dr. Lutfi Kirdar City Hospital
    • Contact: Feyza Esen; Phone Number: +90 505 724 32 56; Email: feyzahusrevoglu@hotmail.com
  • Izmir, Turkey (Türkiye)
    • Recruiting
    • Dokuz Eylul University Faculty of Medicine
    • Contact: Emel Ulusoy; Phone Number: +90 506 914 00 08; Email: ulusoy.emel@deu.edu.tr
  • Kayseri, Turkey (Türkiye)
    • Recruiting
    • Kayseri City Hospital
    • Contact: Murat Dogan, MD; Phone Number: +905059025999; Email: doktormurat033@hotmail.com
  • Manisa, Turkey (Türkiye)
    • Recruiting
    • Celal Bayar University Faculty of Medicine
    • Contact: Alkan Bal, MD; Phone Number: +90 505 815 01 33; Email: balalkan@hotmail.com
  • Tokat Province, Turkey (Türkiye)
    • Recruiting
    • Tokat University Faculty of Medicine
    • Contact: Seda Gumustekin Bilgin; Phone Number: +90 554 206 60 04; Email: dr.seda.cocukacil@gmail.com
  • Talas
    • Kayseri, Talas, Turkey (Türkiye), 38039
      • Recruiting
      • Erciyes University Faculty of Medicine
      • Contact: Yilmaz Secilmis, MD; Phone Number: +905063013174; Email: yilmazsecilmis@erciyes.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.

Description

Inclusion Criteria:

• Age 0-18 years
• Presentation to the pediatric emergency department
• Fever >=38.0 C at triage OR history of fever within the preceding 24 hours

Exclusion Criteria:

• Presentation due to trauma
• Elective visits
• Missing triage data
• Re-attendance within 72 hours for the same episode (only the first visit is included)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Febrile children in the pediatric emergency department; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 Dys

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admission with intravenous antibiotics	Hospital admission with intravenous antibiotic treatment for at least 24 hours.	Up to 30 days
Sepsis protocol activation	Activation of an institutional sepsis protocol during the index emergency department visit.	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.	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.	72 hours
All-cause hospital ward admission	Admission to a hospital ward for any cause.	Index ED visit (day 1)
Undertriage rate	Proportion of Green-triaged patients who develop the primary composite outcome.	30 days
Overtriage rate	Proportion of Red-triaged patients who do not develop the primary composite outcome.	30 days

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Collaborators: Cukurova University; Akdeniz University; Dokuz Eylul University; Tokat Gaziosmanpasa University; Adana City Training and Research Hospital; Eskisehir Osmangazi University; Kayseri City Hospital; Manisa Celal Bayar University; Lütfi Kırdar City Hospital
• Investigators: Principal Investigator: Yilmaz Secilmis, TC Erciyes University

Publications and helpful links

General Publications

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.
• Fleming S, Thompson M, Stevens R, Heneghan C, Pluddemann A, Maconochie I, Tarassenko L, Mant D. Normal ranges of heart rate and respiratory rate in children from birth to 18 years of age: a systematic review of observational studies. Lancet. 2011 Mar 19;377(9770):1011-8. doi: 10.1016/S0140-6736(10)62226-X.
• Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
• Collins GS, Reitsma JB, Altman DG, Moons KG. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015 Jan 6;162(1):55-63. doi: 10.7326/M14-0697.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 5, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: emergency department; physiological parameters; febrile children; undertriage; clinical prediction model; pediatric triage
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Sepsis; Fever
• Other Study ID Numbers: ERU-PEDTRIAGE-2026; 2026/382 (Other Identifier: Erciyes University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No