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NCT Number: NCT07624955

Comparison of the BIG Score and the Pediatric Trauma Score

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.

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Key information

Conditions

Pediatric Trauma Patients

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Base excess, International normalized ratio(INR)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdel Moneim, Professor

CONTACT

+201005768450

Mohamed Kadry Elsayed, Resident

CONTACT

[email protected]

+201152295048

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Comparison of the BIG Score and the Pediatric Trauma Score in Predicting Mortality Among Pediatric Trauma Patients.

Acronym: BIG|PTS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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