Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department (PEDTRIAGE)
3 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Observationnel
Inscription (Estimé)
3000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yilmaz Secilmis, MD
- Numéro de téléphone: +905063013174
- E-mail: yilmazsecilmis@erciyes.edu.tr
Lieux d'étude
-
-
-
Adana, Turquie (Türkiye)
- Recrutement
- Adana City Training and Research Hospital
-
Contact:
- Saadetnur Bozgeyik Aksoy, MD
- Numéro de téléphone: +90 05077185767
- E-mail: saadetnb@gmail.com
-
Adana, Turquie (Türkiye)
- Recrutement
- Cukurova University Faculty of Medicine
-
Contact:
- Sevcan Bilen, MD
- Numéro de téléphone: +90 532 276 50 84
- E-mail: svcnbln@hotmail.com
-
Antalya, Turquie (Türkiye)
- Recrutement
- Akdeniz University Faculty of Medicine
-
Contact:
- Ozlem Tolu Kendir, MD
- Numéro de téléphone: +90 505 304 98 09
- E-mail: otolu80@yahoo.com
-
Eskişehir, Turquie (Türkiye)
- Recrutement
- Osmangazi University Faculty of Medicine
-
Contact:
- Emre Gungor, MD
- Numéro de téléphone: +90 506 425 52 40
- E-mail: emregungormd@gmail.com
-
Istanbul, Turquie (Türkiye)
- Recrutement
- Kartal Dr. Lutfi Kirdar City Hospital
-
Contact:
- Feyza Esen
- Numéro de téléphone: +90 505 724 32 56
- E-mail: feyzahusrevoglu@hotmail.com
-
Izmir, Turquie (Türkiye)
- Recrutement
- Dokuz Eylul University Faculty of Medicine
-
Contact:
- Emel Ulusoy
- Numéro de téléphone: +90 506 914 00 08
- E-mail: ulusoy.emel@deu.edu.tr
-
Kayseri, Turquie (Türkiye)
- Recrutement
- Kayseri City Hospital
-
Contact:
- Murat Dogan, MD
- Numéro de téléphone: +905059025999
- E-mail: doktormurat033@hotmail.com
-
Manisa, Turquie (Türkiye)
- Recrutement
- Celal Bayar University Faculty of Medicine
-
Contact:
- Alkan Bal, MD
- Numéro de téléphone: +90 505 815 01 33
- E-mail: balalkan@hotmail.com
-
Tokat Province, Turquie (Türkiye)
- Recrutement
- Tokat University Faculty of Medicine
-
Contact:
- Seda Gumustekin Bilgin
- Numéro de téléphone: +90 554 206 60 04
- E-mail: dr.seda.cocukacil@gmail.com
-
-
Talas
-
Kayseri, Talas, Turquie (Türkiye), 38039
- Recrutement
- Erciyes University Faculty of Medicine
-
Contact:
- Yilmaz Secilmis, MD
- Numéro de téléphone: +905063013174
- E-mail: yilmazsecilmis@erciyes.edu.tr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
La 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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Composite serious clinical outcome
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hospital admission with intravenous antibiotics
Délai: Up to 30 days
|
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
|
Up to 30 days
|
|
Sepsis protocol activation
Délai: 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
Délai: 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
Délai: 72 hours
|
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
|
72 hours
|
|
All-cause hospital ward admission
Délai: Index ED visit (day 1)
|
Admission to a hospital ward for any cause.
|
Index ED visit (day 1)
|
|
Undertriage rate
Délai: 30 days
|
Proportion of Green-triaged patients who develop the primary composite outcome.
|
30 days
|
|
Overtriage rate
Délai: 30 days
|
Proportion of Red-triaged patients who do not develop the primary composite outcome.
|
30 days
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Yilmaz Secilmis, TC Erciyes University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 juillet 2026
Achèvement primaire (Estimé)
1 novembre 2026
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
27 juillet 2026
Première soumission répondant aux critères de contrôle qualité
27 juillet 2026
Première publication (Réel)
31 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ERU-PEDTRIAGE-2026
- 2026/382 (Autre identifiant: Erciyes University Clinical Research Ethics Committee)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .