Triage Performance and Physiological Predictors of Serious Illness in Febrile Children in the Pediatric Emergency Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorTC Erciyes University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Consecutive children aged 0-18 years presenting with fever to the participating pediatric emergency departments during the study period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ministry of Health three-level color-coded triage
Diagnostic testAt 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.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Febrile children in the pediatric emergency department1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 DysSecondary outcomes
1
Hospital admission with intravenous antibiotics
Hospital admission with intravenous antibiotic treatment for at least 24 hours.
Time frame
Up to 30 days2
Sepsis protocol activation
Activation of an institutional sepsis protocol during the index emergency department visit.
Time frame
Index ED visit (day 1)3
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.
Time frame
Index ED visit (day 1)4
Unplanned re-attendance with admission
Re-attendance within 72 hours followed by admission to a ward or intensive care unit.
Time frame
72 hoursSponsors and contacts
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TC Erciyes University
Lead sponsor
Kayseri City Hospital
Collaborator
Adana City Training and Research Hospital
Collaborator
Cukurova University
Collaborator
Akdeniz University
Collaborator
Manisa Celal Bayar University
Collaborator
Eskisehir Osmangazi University
Collaborator
Lütfi Kırdar City Hospital
Collaborator
Dokuz Eylul University
Collaborator
Tokat Gaziosmanpasa University
Collaborator
Source ClinicalTrials.gov