Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department (PEDTRIAGE)
3. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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).
Studietype
Observasjonsmessig
Registrering (Antatt)
3000
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yilmaz Secilmis, MD
- Telefonnummer: +905063013174
- E-post: yilmazsecilmis@erciyes.edu.tr
Studiesteder
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Adana, Tyrkia (Türkiye)
- Rekruttering
- Adana City Training and Research Hospital
-
Ta kontakt med:
- Saadetnur Bozgeyik Aksoy, MD
- Telefonnummer: +90 05077185767
- E-post: saadetnb@gmail.com
-
Adana, Tyrkia (Türkiye)
- Rekruttering
- Cukurova University Faculty of Medicine
-
Ta kontakt med:
- Sevcan Bilen, MD
- Telefonnummer: +90 532 276 50 84
- E-post: svcnbln@hotmail.com
-
Antalya, Tyrkia (Türkiye)
- Rekruttering
- Akdeniz University Faculty of Medicine
-
Ta kontakt med:
- Ozlem Tolu Kendir, MD
- Telefonnummer: +90 505 304 98 09
- E-post: otolu80@yahoo.com
-
Eskişehir, Tyrkia (Türkiye)
- Rekruttering
- Osmangazi University Faculty of Medicine
-
Ta kontakt med:
- Emre Gungor, MD
- Telefonnummer: +90 506 425 52 40
- E-post: emregungormd@gmail.com
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Istanbul, Tyrkia (Türkiye)
- Rekruttering
- Kartal Dr. Lutfi Kirdar City Hospital
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Ta kontakt med:
- Feyza Esen
- Telefonnummer: +90 505 724 32 56
- E-post: feyzahusrevoglu@hotmail.com
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Izmir, Tyrkia (Türkiye)
- Rekruttering
- Dokuz Eylul University Faculty of Medicine
-
Ta kontakt med:
- Emel Ulusoy
- Telefonnummer: +90 506 914 00 08
- E-post: ulusoy.emel@deu.edu.tr
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Kayseri, Tyrkia (Türkiye)
- Rekruttering
- Kayseri City Hospital
-
Ta kontakt med:
- Murat Dogan, MD
- Telefonnummer: +905059025999
- E-post: doktormurat033@hotmail.com
-
Manisa, Tyrkia (Türkiye)
- Rekruttering
- Celal Bayar University Faculty of Medicine
-
Ta kontakt med:
- Alkan Bal, MD
- Telefonnummer: +90 505 815 01 33
- E-post: balalkan@hotmail.com
-
Tokat Province, Tyrkia (Türkiye)
- Rekruttering
- Tokat University Faculty of Medicine
-
Ta kontakt med:
- Seda Gumustekin Bilgin
- Telefonnummer: +90 554 206 60 04
- E-post: dr.seda.cocukacil@gmail.com
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-
Talas
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Kayseri, Talas, Tyrkia (Türkiye), 38039
- Rekruttering
- Erciyes University Faculty of Medicine
-
Ta kontakt med:
- Yilmaz Secilmis, MD
- Telefonnummer: +905063013174
- E-post: yilmazsecilmis@erciyes.edu.tr
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Yilmaz Secilmis, TC Erciyes University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. juli 2026
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
27. juli 2026
Først innsendt som oppfylte QC-kriteriene
27. juli 2026
Først lagt ut (Faktiske)
31. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ERU-PEDTRIAGE-2026
- 2026/382 (Annen identifikator: Erciyes University Clinical Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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