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

Triage Performance and Physiological Parameters Predicting Serious Illness in Children Presenting With Fever to the Pediatric Emergency Department: A Multicenter Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07739004
Acronym
PEDTRIAGE
Enrollment
3000
Registered
2026-07-31
Start date
2026-07-28
Completion date
2026-12-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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).

Interventions

DIAGNOSTIC_TESTMinistry 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.

Sponsors

TC Erciyes University
Lead SponsorOTHER
Kayseri City Hospital
CollaboratorOTHER_GOV
Adana City Training and Research Hospital
CollaboratorOTHER
Cukurova University
CollaboratorOTHER
Akdeniz University
CollaboratorOTHER
Manisa Celal Bayar University
CollaboratorOTHER
Eskisehir Osmangazi University
CollaboratorOTHER
Lütfi Kırdar City Hospital
CollaboratorOTHER
Dokuz Eylul University
CollaboratorOTHER
Tokat Gaziosmanpasa University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Composite serious clinical outcome30 DysPresence 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.

Secondary

MeasureTime frameDescription
Hospital admission with intravenous antibioticsUp to 30 daysHospital admission with intravenous antibiotic treatment for at least 24 hours.
Sepsis protocol activationIndex ED visit (day 1)Activation of an institutional sepsis protocol during the index emergency department visit.
Intravenous fluid bolus of at least 20 mL/kgIndex ED visit (day 1)Administration of an intravenous fluid bolus of at least 20 mL/kg during the index emergency department visit.
Unplanned re-attendance with admission72 hoursRe-attendance within 72 hours followed by admission to a ward or intensive care unit.
All-cause hospital ward admissionIndex ED visit (day 1)Admission to a hospital ward for any cause.
Undertriage rate30 daysProportion of Green-triaged patients who develop the primary composite outcome.
Overtriage rate30 daysProportion of Red-triaged patients who do not develop the primary composite outcome.

Countries

Turkey (Türkiye)

Contacts

CONTACTYilmaz Secilmis, MD
yilmazsecilmis@erciyes.edu.tr+905063013174
PRINCIPAL_INVESTIGATORYilmaz Secilmis

TC Erciyes University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026