Comparison of the BIG Score and the Pediatric Trauma Score (BIG|PTS)

May 30, 2026 updated by: Mohamed Kadry Elsayed, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Mohamed Abdel Moneim, Professor
  • Phone Number: +201005768450

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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 .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

Other Names:
  • Base excess
  • International normalized ratio(INR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality among pediatric trauma patients.
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU admission among pediatric trauma patients.
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Mohamed Kadry Elsayed, Resident, Faculty of medicine Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

January 10, 2027

Study Completion (Estimated)

February 10, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-26-5-1MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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