- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07624955
Comparison of the BIG Score and the Pediatric Trauma Score (BIG|PTS)
Comparison of the BIG Score and the Pediatric Trauma Score in Predicting Mortality Among Pediatric Trauma Patients.
The goal of this observational study is to evaluate and compare the predictive performance of the BIG Score and the Pediatric Trauma Score (PTS) in predicting mortality among pediatric trauma patients presenting to the emergency department.
The main questions it aims to answer are:
Does the BIG Score accurately predict mortality in pediatric trauma patients?
Is the Pediatric Trauma Score (PTS) effective in predicting mortality among pediatric trauma patients?
Which scoring system demonstrates better sensitivity, specificity, and overall predictive accuracy for mortality?
Researchers will compare the BIG Score with the Pediatric Trauma Score to determine which scoring system provides superior prognostic value in pediatric trauma cases.
Participants will:
Undergo routine clinical assessment upon admission to the emergency department.
Have vital signs, Glasgow Coma Scale (GCS), and trauma-related clinical parameters recorded.
Undergo laboratory investigations including Base Deficit and International Normalized Ratio (INR).
Be followed during hospitalization to assess outcomes, including survival or mortality.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study focuses on assessing the clinical usefulness of two pediatric trauma scoring systems in emergency settings and determining their role in early prognostic evaluation after traumatic injury. Accurate prediction of patient outcomes during the initial hours of admission is essential for prioritizing management decisions, optimizing intensive care utilization, and improving overall quality of trauma care.
The BIG Score incorporates biochemical and neurological indicators that reflect the physiological impact of trauma, while the Pediatric Trauma Score relies mainly on bedside clinical findings obtained during the primary assessment. Evaluating the performance of these tools in real clinical practice may help identify the most practical and reliable method for risk stratification among injured children.
Data collection will include demographic characteristics, type and mechanism of trauma, hemodynamic status at presentation, neurological findings, and relevant laboratory parameters obtained during the initial emergency evaluation. Both scores will be calculated for each patient shortly after admission and analyzed in relation to clinical outcomes observed during hospitalization.
The study will also explore the association between trauma severity scores and the need for advanced supportive measures such as intensive care admission, ventilatory support, blood product administration, and prolonged hospitalization. Statistical analysis will be performed to determine the prognostic performance and clinical applicability of each scoring system in pediatric trauma assessment.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed Kadry Elsayed, Resident
- Número de teléfono: +201152295048
- Correo electrónico: Mohamed.Kadry@med.sohag.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Ahmed Mohamed Abdel Moneim, Professor
- Número de teléfono: +201005768450
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Pediatric trauma patients from birth up to 16 years of age.
- Presentation to the Emergency Department within 24 hours of the primary injury.
Exclusion Criteria:
- Patients with minor traumas who are treated and discharged directly from the ED.
- Patients initially managed at and referred from another hospital.
- Patients whose legal guardians discharge them against medical advice (AMA) before outcome data can be ascertained.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Pediatric patients presenting to the emergency department with traumatic injury.
Pediatric trauma patients presenting to the emergency department and meeting the inclusion criteria will be enrolled.
Clinical data, laboratory parameters, BIG Score, and Pediatric Trauma Score (PTS) will be collected at admission to evaluate their ability to predict in-hospital mortality, ICU admission, and the need for emergency surgical intervention.
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Pediatric trauma patients presenting to the emergency department will undergo routine clinical and laboratory evaluation according to institutional trauma management protocols. Upon admission, physiological and laboratory parameters required for calculation of the BIG Score and the Pediatric Trauma Score (PTS) will be collected. The BIG Score will be determined using Base Deficit, International Normalized Ratio (INR), and Glasgow Coma Scale (GCS), while the Pediatric Trauma Score will be calculated using airway status, systolic blood pressure, level of consciousness, skeletal injury, cutaneous injury, and body weight. Both scores will be assessed during the initial evaluation phase and correlated with patient outcomes, including mortality, intensive care unit admission, need for mechanical ventilation, blood transfusion, and length of hospital stay. No additional therapeutic intervention beyond standard trauma care will be introduced as part of the study.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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In-hospital mortality among pediatric trauma patients.
Periodo de tiempo: From admission to discharge (up to 30 days)
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The proportion of enrolled pediatric trauma patients who die during hospitalization within 30 days of admission.
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From admission to discharge (up to 30 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ICU admission among pediatric trauma patients.
Periodo de tiempo: From admission to discharge (up to 30 days)
|
The proportion of enrolled pediatric trauma patients requiring admission to the intensive care unit during hospitalization will be assessed.
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From admission to discharge (up to 30 days)
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Emergency surgical intervention among pediatric trauma patients
Periodo de tiempo: From admission to discharge (up to 30 days)
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The proportion of enrolled pediatric trauma patients requiring emergency surgical intervention during hospitalization will be assessed .
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From admission to discharge (up to 30 days)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed Kadry Elsayed, Resident, Faculty of Medicine Sohag University
Publicaciones y enlaces útiles
Publicaciones Generales
- Az A, Dogan Y, Sogut O, Akdemir T. Comparison of the BIG Score and Pediatric Trauma Score for Predicting Mortality. Pediatr Emerg Care. 2024 Dec 1;40(12):839-843. doi: 10.1097/PEC.0000000000003267. Epub 2024 Aug 27.
- Schuster A, Klute L, Kerschbaum M, Kunkel J, Schaible J, Straub J, Weber J, Alt V, Popp D. Injury Pattern and Current Early Clinical Care of Pediatric Polytrauma Comparing Different Age Groups in a Level I Trauma Center. J Clin Med. 2024 Jan 22;13(2):639. doi: 10.3390/jcm13020639.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Soh-Med-26-5-1MS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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