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

3 augustus 2026 bijgewerkt door: Yılmaz Seçilmiş, TC Erciyes University

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Observationeel

Inschrijving (Geschat)

3000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
      • Adana, Turkije (Türkiye)
        • Werving
        • Adana City Training and Research Hospital
        • Contact:
      • Adana, Turkije (Türkiye)
        • Werving
        • Cukurova University Faculty of Medicine
        • Contact:
      • Antalya, Turkije (Türkiye)
        • Werving
        • Akdeniz University Faculty of Medicine
        • Contact:
      • Eskişehir, Turkije (Türkiye)
        • Werving
        • Osmangazi University Faculty of Medicine
        • Contact:
      • Istanbul, Turkije (Türkiye)
        • Werving
        • Kartal Dr. Lutfi Kirdar City Hospital
        • Contact:
      • Izmir, Turkije (Türkiye)
        • Werving
        • Dokuz Eylul University Faculty of Medicine
        • Contact:
      • Kayseri, Turkije (Türkiye)
      • Manisa, Turkije (Türkiye)
        • Werving
        • Celal Bayar University Faculty of Medicine
        • Contact:
      • Tokat Province, Turkije (Türkiye)
        • Werving
        • Tokat University Faculty of Medicine
        • Contact:
    • Talas
      • Kayseri, Talas, Turkije (Türkiye), 38039
        • Werving
        • Erciyes University Faculty of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Diagnostische toets: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite serious clinical outcome
Tijdsspanne: 30 Dys
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hospital admission with intravenous antibiotics
Tijdsspanne: Up to 30 days
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
Up to 30 days
Sepsis protocol activation
Tijdsspanne: Index ED visit (day 1)
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
Tijdsspanne: Index ED visit (day 1)
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
Tijdsspanne: 72 hours
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
72 hours
All-cause hospital ward admission
Tijdsspanne: Index ED visit (day 1)
Admission to a hospital ward for any cause.
Index ED visit (day 1)
Undertriage rate
Tijdsspanne: 30 days
Proportion of Green-triaged patients who develop the primary composite outcome.
30 days
Overtriage rate
Tijdsspanne: 30 days
Proportion of Red-triaged patients who do not develop the primary composite outcome.
30 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

TC Erciyes University

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Yilmaz Secilmis, TC Erciyes University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 juli 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

27 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2026

Eerst geplaatst (Werkelijk)

31 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ERU-PEDTRIAGE-2026
  • 2026/382 (Andere identificatie: Erciyes University Clinical Research Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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