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

30. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Ahmed Mohamed Abdel Moneim, Professor
  • Telefonnummer: +201005768450

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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 .

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.

Andre navne:
  • Base excess
  • International normalized ratio(INR)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
In-hospital mortality among pediatric trauma patients.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU admission among pediatric trauma patients.
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sohag University

Efterforskere

  • Ledende efterforsker: Mohamed Kadry Elsayed, Resident, Faculty of medicine Sohag University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juni 2026

Primær færdiggørelse (Anslået)

10. januar 2027

Studieafslutning (Anslået)

10. februar 2027

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

30. maj 2026

Først opslået (Faktiske)

3. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Soh-Med-26-5-1MS

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med blood sampling

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