- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704814
Baseline Evaluation of Lymph Nodes in the Lower Quadrant Young People Using Point of Care Ultrasound (BELLY-POCUS) (BELLY POCUS)
Baseline Evaluation of Lymph Nodes in the Lower Quadrant Young People Using Point of Care Ultrasound
Abdominal pain is one of the commonest presentations to the paediatric emergency department. Many children are brought to the PED due to concerns about surgical intra-abdominal pathology such as appendicitis. Mesenteric adenitis is commonly attributed as a cause of the patient's pain but is done so without confirmatory imaging findings and as a diagnosis of exclusion.
There is a paucity of evidence pertaining to the sonographic findings of mesenteric adenitis.
We aim to categorise the normal appearances using POCUS in patients presenting to the paediatric emergency department without any abdominal or infectious complaint, in order to describe the range of normal lymph node numbers and size present on scan. By defining what's normal, the ultimate aim will be to use POCUS to actively identify abnormalities that diagnose mesenteric adenitis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: David McCreary, MBBS MRCPCH PgC US
- Phone Number: +447399538119
- Email: david.mccreary2@nhs.net
Study Locations
-
-
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Sunderland, United Kingdom
- Recruiting
- Sunderland Royal Hospital
-
Contact:
- David McCreary, MBBS MRCPCH PgC US
- Email: david.mccreary2@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients who present to the paediatric emergency department with the following conditions: head injury, facial injury, neck injury, upper and lower limb injury.
This will take place across 5 hospital sites in the UK, USA and Australia
Description
Inclusion Criteria:
- patients aged 2 - 16 years who present to the paediatric emergency department with the following conditions: head injury, facial injury, neck injury, upper and lower limb injury.
Exclusion Criteria:
- any child who has had symptoms of vomiting (including those with concurrent head injury), diarrhoea, abdominal pain, anorexia, temperature or active evidence of urinary or respiratory tract infection within the last four weeks.
Any patient who has undergone abdominal surgery in the last 6 months.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and sizes of lymph nodes present in the right lower quadrant on abdominal POCUS
Time Frame: 6 months
|
To describe the normal range, in terms of the number and size of lymph nodes present in the right lower quadrant on abdominal POCUS in asymptomatic children.
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Awaited
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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