Head TraumaNCT06768710
PECARN Versus NICE Guidelines for Pediatric Head Trauma in Emergency Department in Assuit and Sohag University Hospitals
An observational study of Head Trauma, run by Sohag University.
Trial summary
the safety and validity of the PECARN with 100% sensitivity in both age groups in identifying patients with ciTBI and theoretically in reducing performed CT scans by 29%. Therefore, in patients classified in the low-risk category, it is a duty not to expose the child to ionizing radiation. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Head Trauma
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2026
- 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: patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice
Who may be able to join
- All patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice.
Who cannot join
- -Patients unstable to had a CT scan.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
the safety and validity of the PECARN with 100% sensitivity in both age groups in identifying patients with ciTBI and theoretically in reducing performed CT scans by 29%. Therefore, in patients classified in the low-risk category, it is a duty not to expose the child to ionizing radiation.
the NICE criteria can minimize the number of CT scans conducted while maintaining a fair sensitivity for identifying patients with TBI and those requiring neurosurgical intervention the sensitivity of the intracranial damage NICE criteria was 93% for early presenters.
Read more
This study is conducted to detect which guidelines can be followed to detect all intracranial lesions with minimizing the number of unnecessary CT scans.
the aim of the study is to evaluate safety and efficacy (sensitivity and specificity) of PECARN and NICE guidelines for detection of traumatic brain injury as compared to current clinical practice in emergency setting and Detection of intracranial findings on CT brain and detection of lesions that need neurosurgical intervention.
Significance of the study:
Read the detailed description
Head trauma in children is one of the most common causes for emergency department (ED) visits. Most head trauma incidents in children visiting the ED are minor; however, identifying those patients who have clinically important traumatic brain injury (ciTBI) is challenging.
A cranial computed tomography (CT) scan is the standard diagnostic test and is widely used all over the world. Although cranial CT scans are useful for definitive diagnosis, potential cancer risks exist associated with ionizing radiation, particularly in children, who are more radiosensitive than adults.
Head trauma prediction rules have been derived for supporting phyiscians to improve accuracy in decision-making and to minimize the use of potentially harmful CT scans. The Pediatric Emergency Care Applied Research Network (PECARN) developed two age-based head trauma prediction rules to identify children with very low risk of ciTBI who do not require cranial CT scans .
The PECARN rule was statistically derived to identify children at very low risk of ciTBI for whom a CT scan could safely be avoided based on the absence of predictor variables. In the presence of predictor variables, the algorithm stratifies the management of children into an intermediate-risk or high-risk group based on the risk of ciTBI. Children at high risk are recommended to have a CT scan as the risk of ciTBI outweighs the risks associated with radiation exposure.
NICE guideline: This guideline covers assessment and early management of head injury in infants, children, young people and adults. It aims to ensure that people have the right care for the severity of their head injury, including direct referral to specialist care if needed. This guideline has updated some of the terminology used in relation to safeguarding people under 16. according to algorithm 2 page8.
- Conditions
- Head Trauma
- Keywords
- NICE Guidelines, PECARN Guidelines
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| head trauma patients | patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of PECARN guidelines
evaluate the accuracy of PECARN guidelines for detection of traumatic brain injury
Measured: 30 day
the accuracy of NICE guidelines
evaluate the accuracy of NICE guidelines for detection of traumatic brain injury
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head TraumaStudies 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Badran Abdelmawgoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768710
- Sponsor's protocol ID
- PECARN vs NICE head trauma
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PECARN Versus NICE Guidelines for Pediatric Head Trauma in Emergency Department in Assuit and Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT06768710
- Acronym / sponsor ID
- PECARN vs NICE head trauma
- Conditions
- Head Trauma
- Keywords
- NICE Guidelines, PECARN Guidelines
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Jan 2025 (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 safety and validity of the PECARN with 100% sensitivity in both age groups in identifying patients with ciTBI and theoretically in reducing performed CT scans by 29%. Therefore, in patients classified in the low-risk category, it is a duty not to expose the child to ionizing radiation.
the NICE criteria can minimize the number of CT scans conducted while maintaining a fair sensitivity for identifying patients with TBI and those requiring neurosurgical intervention the sensitivity of the intracranial damage NICE criteria was 93% for early presenters.
This study is conducted to detect which guidelines can be followed to detect all intracranial lesions with minimizing the number of unnecessary CT scans.
the aim of the study is to evaluate safety and efficacy (sensitivity and specificity) of PECARN and NICE guidelines for detection of traumatic brain injury as compared to current clinical practice in emergency setting and Detection of intracranial findings on CT brain and detection of lesions that need neurosurgical intervention.
Significance of the study:
Detailed description
Head trauma in children is one of the most common causes for emergency department (ED) visits. Most head trauma incidents in children visiting the ED are minor; however, identifying those patients who have clinically important traumatic brain injury (ciTBI) is challenging.
A cranial computed tomography (CT) scan is the standard diagnostic test and is widely used all over the world. Although cranial CT scans are useful for definitive diagnosis, potential cancer risks exist associated with ionizing radiation, particularly in children, who are more radiosensitive than adults.
Head trauma prediction rules have been derived for supporting phyiscians to improve accuracy in decision-making and to minimize the use of potentially harmful CT scans. The Pediatric Emergency Care Applied Research Network (PECARN) developed two age-based head trauma prediction rules to identify children with very low risk of ciTBI who do not require cranial CT scans .
The PECARN rule was statistically derived to identify children at very low risk of ciTBI for whom a CT scan could safely be avoided based on the absence of predictor variables. In the presence of predictor variables, the algorithm stratifies the management of children into an intermediate-risk or high-risk group based on the risk of ciTBI. Children at high risk are recommended to have a CT scan as the risk of ciTBI outweighs the risks associated with radiation exposure.
NICE guideline: This guideline covers assessment and early management of head injury in infants, children, young people and adults. It aims to ensure that people have the right care for the severity of their head injury, including direct referral to specialist care if needed. This guideline has updated some of the terminology used in relation to safeguarding people under 16. according to algorithm 2 page8.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| head trauma patients | – | –patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice
Key inclusion criteria (1 listed)
- All patients less than 16 years old with head trauma indicated for CT brain according to current clinical practice.
Key exclusion criteria (1 listed)
- -Patients unstable to had a CT scan.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the accuracy of PECARN guidelines
Time frame: 30 day
evaluate the accuracy of PECARN guidelines for detection of traumatic brain injury
the accuracy of NICE guidelines
Time frame: 30 day
evaluate the accuracy of NICE guidelines for detection of traumatic brain injury
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 10 Jan 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Trauma, 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 1 inclusion and 1 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 10 Jan 2025. 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 Noha Badran Abdelmougod, resident doctor (+201063409171, noha.badran@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the accuracy of PECARN guidelines (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.