FeverPEDTRIAGENCT07739004
Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department
An observational study of Fever and Triage, run by TC Erciyes University at 10 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Fever, Triage, Pediatric Emergency Medicine
- What is being tested?
- Ministry of Health three-level color-coded triage
- How many people
- 3,000 participants
- Where
- 10 sitesTurkey (Türkiye)
- Study dates
- 28 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
Who may be able to join
- 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
Who cannot join
- Presentation due to trauma
- Elective visits
- Missing triage data
- Re-attendance within 72 hours for the same episode (only the first visit is included)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Turkey (Türkiye)10 sites, 10 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana
Saadetnur Bozgeyik Aksoy, MD, +90 05077185767, saadetnb@gmail.com
- Recruiting
Cukurova University Faculty of Medicine
Adana
Sevcan Bilen, MD, +90 532 276 50 84, svcnbln@hotmail.com
- Recruiting
Akdeniz University Faculty of Medicine
Antalya
Ozlem Tolu Kendir, MD, +90 505 304 98 09, otolu80@yahoo.com
- Recruiting
Osmangazi University Faculty of Medicine
Eskişehir
Emre Gungor, MD, +90 506 425 52 40, emregungormd@gmail.com
- Recruiting
Kartal Dr. Lutfi Kirdar City Hospital
Istanbul
Feyza Esen, +90 505 724 32 56, feyzahusrevoglu@hotmail.com
- Recruiting
Dokuz Eylul University Faculty of Medicine
Izmir
Emel Ulusoy, +90 506 914 00 08, ulusoy.emel@deu.edu.tr
- Recruiting
Erciyes University Faculty of Medicine
Kayseri, Talas, 38039
Yilmaz Secilmis, MD, +905063013174, yilmazsecilmis@erciyes.edu.tr
- Recruiting
Kayseri City Hospital
Kayseri
Murat Dogan, MD, +905059025999, doktormurat033@hotmail.com
- Recruiting
Celal Bayar University Faculty of Medicine
Manisa
Alkan Bal, MD, +90 505 815 01 33, balalkan@hotmail.com
- Recruiting
Tokat University Faculty of Medicine
Tokat Province
Seda Gumustekin Bilgin, +90 554 206 60 04, dr.seda.cocukacil@gmail.com
About this study
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
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.
Read the 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).
- Conditions
- Fever, Triage, Pediatric Emergency Medicine, Serious Bacterial Infection, Sepsis
- Being tested
- Ministry of Health three-level color-coded triage
- Keywords
- pediatric triage, febrile children, clinical prediction model, emergency department, physiological parameters, undertriage
- Medical subject headings
- Fever, Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ministry of Health three-level color-coded triageDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ministry of Health three-level color-coded triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite serious clinical outcome
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.
Measured: 30 Dys
Secondary outcomes (7)
Hospital admission with intravenous antibiotics
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
Measured: Up to 30 days
Sepsis protocol activation
Activation of an institutional sepsis protocol during the index emergency department visit.
Measured: Index ED visit (day 1)
Intravenous fluid bolus of at least 20 mL/kg
Administration of an intravenous fluid bolus of at least 20 mL/kg during the index emergency department visit.
Measured: Index ED visit (day 1)
Unplanned re-attendance with admission
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
Measured: 72 hours
All-cause hospital ward admission
Admission to a hospital ward for any cause.
Measured: Index ED visit (day 1)
Undertriage rate
Proportion of Green-triaged patients who develop the primary composite outcome.
Measured: 30 days
Overtriage rate
Proportion of Red-triaged patients who do not develop the primary composite outcome.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start28 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri City Hospital, Adana City Training and Research Hospital, Cukurova University, Akdeniz University, Manisa Celal Bayar University, Eskisehir Osmangazi University, Lütfi Kırdar City Hospital, Dokuz Eylul University, Tokat Gaziosmanpasa University
- Responsible party
- Principal investigator, Yılmaz Seçilmiş, TC Erciyes University
- Investigators
- Yilmaz Secilmis, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739004
- Sponsor's protocol ID
- ERU-PEDTRIAGE-2026
- Other IDs
- 2026/382
- Acronym
- PEDTRIAGE
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 21411136Riley 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.
PubMed 32188600von 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.
PubMed 18064739Collins 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.
PubMed 25560714
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07739004
- Acronym / sponsor ID
- PEDTRIAGE / ERU-PEDTRIAGE-2026
- Conditions
- Fever, Triage, Pediatric Emergency Medicine, Serious Bacterial Infection, Sepsis
- Keywords
- pediatric triage, febrile children, clinical prediction model, emergency department, physiological parameters, undertriage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- Kayseri City Hospital, Adana City Training and Research Hospital, Cukurova University, Akdeniz University, Manisa Celal Bayar University, Eskisehir Osmangazi University, Lütfi Kırdar City Hospital, Dokuz Eylul University, Tokat Gaziosmanpasa University
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Febrile children in the pediatric emergency department | – | Diagnostic Test: Ministry of Health three-level color-coded triageChildren 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. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Presentation due to trauma
- Elective visits
- Missing triage data
- Re-attendance within 72 hours for the same episode (only the first visit is included)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ministry of Health three-level color-coded triageAt 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. | Diagnostic test | Febrile children in the pediatric emergency department |
Primary outcome
Composite serious clinical outcome
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 21411136Fleming 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.
- Background: PubMed 32188600Riley 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.
- Background: PubMed 18064739von 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.
- Background: PubMed 25560714Collins 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yilmaz Secilmis principal investigator
TC Erciyes University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Triage, run by TC Erciyes University at 10 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yilmaz Secilmis, MD (+905063013174, yilmazsecilmis@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite serious clinical outcome (time frame: 30 Dys). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07739004, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.