Pediatric Trauma PatientsBIG|PTSNCT07624955
Comparison of the BIG Score and the Pediatric Trauma Score
An observational study of Pediatric Trauma Patients, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Pediatric Trauma Patients
- What is being tested?
- blood sampling
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2026to 10 Feb 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
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 .
Who may be able to join
- Pediatric trauma patients from birth up to 16 years of age.
- Presentation to the Emergency Department within 24 hours of the primary injury.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed Mohamed Abdel Moneim, Professor contact
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Pediatric Trauma Patients
- Being tested
- blood sampling
- Keywords
- Comparison of the BIG Score and the Pediatric Trauma Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Also called Base excess, International normalized ratio(INR)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality among pediatric trauma patients.
The proportion of enrolled pediatric trauma patients who die during hospitalization within 30 days of admission.
Measured: From admission to discharge (up to 30 days)
Secondary outcomes (2)
ICU admission among pediatric trauma patients.
The proportion of enrolled pediatric trauma patients requiring admission to the intensive care unit during hospitalization will be assessed.
Measured: From admission to discharge (up to 30 days)
Emergency surgical intervention among pediatric trauma patients
The proportion of enrolled pediatric trauma patients requiring emergency surgical intervention during hospitalization will be assessed .
Measured: From admission to discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric Trauma PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kadry Elsayed, Sohag University
- Investigators
- Mohamed Kadry Elsayed, Resident, Principal investigator, Faculty of medicine Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624955
- Sponsor's protocol ID
- Soh-Med-26-5-1MS
- Acronym
- BIG|PTS
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39190391Schuster 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.
PubMed 38276145
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the BIG Score and the Pediatric Trauma Score in Predicting Mortality Among Pediatric Trauma Patients.
- ClinicalTrials.gov ID
- NCT07624955
- Acronym / sponsor ID
- BIG|PTS / Soh-Med-26-5-1MS
- Conditions
- Pediatric Trauma Patients
- Keywords
- Comparison of the BIG Score and the Pediatric Trauma Score
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients presenting to the emergency department with traumatic injury. | – | Diagnostic Test: blood samplingPediatric 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. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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 .
Key inclusion criteria (2 listed)
- Pediatric trauma patients from birth up to 16 years of age.
- Presentation to the Emergency Department within 24 hours of the primary injury.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAlso: Base excess, International normalized ratio(INR)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. | Diagnostic test | Pediatric patients presenting to the emergency department with traumatic injury. |
Primary outcome
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.
2 secondary outcomes
ICU admission among pediatric trauma patients.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Results publication: PubMed 39190391Az 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.
- Results publication: PubMed 38276145Schuster 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Mohamed Abdel Moneim, Professor contact
Mohamed Kadry Elsayed, Resident principal investigator
Faculty of medicine Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Trauma Patients, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Kadry Elsayed, Resident (+201152295048, Mohamed.Kadry@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality among pediatric trauma patients. (time frame: From admission to discharge (up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07624955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.