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

NCT07739004 | Not Yet Recruiting

• 2 other identifiers: ERU-PEDTRIAGE-20262026/382
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Fever; Triage; Pediatric Emergency Medicine; Serious Bacterial Infection; Sepsis

Keywords

pediatric triage; febrile children; clinical prediction model; emergency department; physiological parameters; undertriage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Hospital admission with intravenous antibiotics

  Up to 30 days

• Sepsis protocol activation

  Index ED visit (day 1)

• Intravenous fluid bolus of at least 20 mL/kg

  Index ED visit (day 1)

• Unplanned re-attendance with admission

  72 hours

• All-cause hospital ward admission

  Index ED visit (day 1)

Study Arms (1)

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

Interventions

Ministry of Health three-level color-coded triage DIAGNOSTIC_TEST

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.

Febrile children in the pediatric emergency department

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead
• Kayseri City Hospital: collaborator
• Adana City Training and Research Hospital: collaborator
• Cukurova University: collaborator
• Akdeniz University: collaborator
• Manisa Celal Bayar University: collaborator
• Eskisehir Osmangazi University: collaborator
• Lütfi Kırdar City Hospital: collaborator
• Dokuz Eylul University: collaborator
• Tokat Gaziosmanpasa University: collaborator

Study Sites (10)

Erciyes University Faculty of Medicine

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Location

Cukurova University Faculty of Medicine

Adana, Turkey (Türkiye)

Location

Akdeniz University Faculty of Medicine

Antalya, Turkey (Türkiye)

Location

Osmangazi University Faculty of Medicine

Eskişehir, Turkey (Türkiye)

Location

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylul University Faculty of Medicine

Izmir, Turkey (Türkiye)

Location

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

Celal Bayar University Faculty of Medicine

Manisa, Turkey (Türkiye)

Location

Tokat University Faculty of Medicine

Tokat Province, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21411136 BACKGROUND

• 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.

  PMID: 32188600 BACKGROUND

• 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.

  PMID: 18064739 BACKGROUND

• 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.

  PMID: 25560714 BACKGROUND

MeSH Terms

Conditions

Fever; Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Disease Attributes

Study Officials

• Yilmaz Secilmis

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yilmaz Secilmis, MD

CONTACT

+905063013174; yilmazsecilmis@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (10)