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

Official title

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

Overview

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 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.

Primary outcome measures

• Composite serious clinical outcome [Time frame: 30 Dys]

Secondary outcome measures (7)

• Hospital admission with intravenous antibiotics [Time frame: Up to 30 days]
• Sepsis protocol activation [Time frame: Index ED visit (day 1)]
• Intravenous fluid bolus of at least 20 mL/kg [Time frame: Index ED visit (day 1)]
• Unplanned re-attendance with admission [Time frame: 72 hours]
• All-cause hospital ward admission [Time frame: Index ED visit (day 1)]
• Undertriage rate [Time frame: 30 days]
• Overtriage rate [Time frame: 30 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 10 centers

• Erciyes University Faculty of Medicine — Kayseri
• Adana City Training and Research Hospital — Adana
• Cukurova University Faculty of Medicine — Adana
• Akdeniz University Faculty of Medicine — Antalya
• Osmangazi University Faculty of Medicine — Eskişehir
• Kartal Dr. Lutfi Kirdar City Hospital — Istanbul
• Dokuz Eylul University Faculty of Medicine — Izmir
• Kayseri City Hospital — Kayseri
• … and 2 more centers

Publications

• 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. PMID 21411136
• 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. PMID 32188600
• 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. PMID 18064739
• 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. PMID 25560714

Identifiers

NCT: NCT07739004 · ERU-PEDTRIAGE-2026 · 2026/382

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗