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

3. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

3000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite serious clinical outcome
Tidsramme: 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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

TC Erciyes University

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Yilmaz Secilmis, TC Erciyes University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. juli 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

27. juli 2026

Først indsendt, der opfyldte QC-kriterier

27. juli 2026

Først opslået (Faktiske)

31. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Abonner