Comparison of the BIG Score and the Pediatric Trauma Score

NCT07624955 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-5-1MS
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pediatric Trauma Patients

Keywords

Comparison of the BIG Score and the Pediatric Trauma Score

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality among pediatric trauma patients.

  The proportion of enrolled pediatric trauma patients who die during hospitalization within 30 days of admission.

  From admission to discharge (up to 30 days)

Secondary Outcomes (2)

• ICU admission among pediatric trauma patients.

  From admission to discharge (up to 30 days)

• Emergency surgical intervention among pediatric trauma patients

  From admission to discharge (up to 30 days)

Study Arms (1)

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.

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

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.

Also known as: Base excess, International normalized ratio(INR)

Pediatric patients presenting to the emergency department with traumatic injury.

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include pediatric patients presenting to the emergency department with traumatic injuries and Eligible according to the inclusion criteria during the study period .

You may qualify if:

• Pediatric trauma patients from birth up to 16 years of age.
• Presentation to the Emergency Department within 24 hours of the primary injury.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (2)

• 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.

  PMID: 39190391 RESULT

• 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.

  PMID: 38276145 RESULT

MeSH Terms

Interventions

Blood Specimen Collection; International Normalized Ratio

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Blood Coagulation Tests; Hematologic Tests

Study Officials

• Mohamed Kadry Elsayed, Resident

  Faculty of medicine Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Kadry Elsayed, Resident

CONTACT

+201152295048; Mohamed.Kadry@med.sohag.edu.eg

Ahmed Mohamed Abdel Moneim, Professor

CONTACT

+201005768450

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: June 3, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05