- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Mohamed Kadry Elsayed, Resident
- Número de telefone: +201152295048
- E-mail: Mohamed.Kadry@med.sohag.edu.eg
Estude backup de contato
- Nome: Ahmed Mohamed Abdel Moneim, Professor
- Número de telefone: +201005768450
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
In-hospital mortality among pediatric trauma patients.
Prazo: From admission to discharge (up to 30 days)
|
The proportion of enrolled pediatric trauma patients who die during hospitalization within 30 days of admission.
|
From admission to discharge (up to 30 days)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
ICU admission among pediatric trauma patients.
Prazo: 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.
|
From admission to discharge (up to 30 days)
|
|
Emergency surgical intervention among pediatric trauma patients
Prazo: From admission to discharge (up to 30 days)
|
The proportion of enrolled pediatric trauma patients requiring emergency surgical intervention during hospitalization will be assessed .
|
From admission to discharge (up to 30 days)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed Kadry Elsayed, Resident, Faculty of Medicine Sohag University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Soh-Med-26-5-1MS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .