- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mohamed Kadry Elsayed, Resident
- 전화번호: +201152295048
- 이메일: Mohamed.Kadry@med.sohag.edu.eg
연구 연락처 백업
- 이름: Ahmed Mohamed Abdel Moneim, Professor
- 전화번호: +201005768450
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
In-hospital mortality among pediatric trauma patients.
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ICU admission among pediatric trauma patients.
기간: 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
기간: 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)
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Mohamed Kadry Elsayed, Resident, Faculty of medicine sohag university
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Soh-Med-26-5-1MS
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
소아 외상 환자에 대한 임상 시험
-
Riverside University Health System Medical Center알려지지 않은
blood sampling에 대한 임상 시험
-
Haydarpasa Numune Training and Research Hospital완전한
-
University Hospital, Rouen모병
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)완전한
-
The University of QueenslandBecton, Dickinson and Company모병
-
Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국