Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years
Primary Purpose
Fracture, Abuse Physical
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermal Imaging Camera
Sponsored by
About this trial
This is an interventional diagnostic trial for Fracture
Eligibility Criteria
Inclusion Criteria:
- Children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse
- Healthy Control children
Exclusion Criteria:
- 1. Informed consent withheld by main carer/guardian for the skeletal survey (court order would then be issues) 2. Informed consent for participation in the research study withheld 2. Situations where informed consent cannot be obtained (e.g. inability of carer/guardian to understand written English) 3. Postmortem cases (inclusion of the demised would unduly complicate the consent process for this small pilot study)
Sites / Locations
- Clinical Research Facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infrared Imaging undertaken
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic accuracy of thermal imaging for fracture detection compared to skeletal survey as the gold standard
Diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of thermal imaging compared to the full skeletal survey as gold standard
Secondary Outcome Measures
Potential radiation dose reduction - calculated on the basis of known radiation exposure of the images that form the skeletal survey
Radiation dose saving of a protocol that only images those areas of abnormality seen on thermal imaging compared to the full skeletal survey as gold standard
Carer acceptability/preference of the imaging modalities
Descriptive statistics based on responses to a non-validated questionnaire on carer experiences of both imaging techniques
Full Information
NCT ID
NCT04237454
First Posted
January 3, 2020
Last Updated
January 17, 2020
Sponsor
Sheffield Children's NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04237454
Brief Title
Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years
Official Title
Thermal Imaging Compared to Skeletal Survey for Diagnosis of Fractures in Suspected Inflicted Injury in Children Below 2 Years of Age: A Prospective Diagnostic Accuracy Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
April 11, 2017 (Actual)
Study Completion Date
April 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Children's NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When a child less than 2 years old attends the Emergency Department (ED) with an injury, carers should offer an explanation. When there is no explanation or if the explanation is inconsistent & because the child cannot say what happened, the doctor will need to consider all possible causes including child abuse. To help exclude abuse, the doctor will request x-rays of all the child's bones to make sure there are no other unexplained fractures. This requires up to 20 x-rays, which are called a skeletal survey. Even if there are no fractures, some or all of the x-rays will be repeated in the following 7-21 days, because by that time any fractures will have started to heal and so are easier to see than on the first skeletal survey. It means that if a doctor is worried about abuse, the child may need to have up to 40 x-rays, which amounts to a significant radiation dose (more than 6 months of natural UK background radiation) & increases the child's lifetime risk of getting cancer. 79 to 97 out of 100 skeletal surveys performed are normal. While it is of paramount importance to identify if a child is being abused, it is also important to minimise radiation dose. A camera which detects light and heat given off by the body has shown promise in some areas of medical practice. We plan to compare the results from the camera to those of the skeletal survey in 40 children below 2 years of age attending our hospital over a 6-month period. We hope to demonstrate that this technology can be used to further select children who should have a skeletal survey, reducing radiation dose in children without missing those who are being abused and sending them home to be abused again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Abuse Physical
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Thermal Imaging
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infrared Imaging undertaken
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Thermal Imaging Camera
Intervention Description
To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse
Primary Outcome Measure Information:
Title
Diagnostic accuracy of thermal imaging for fracture detection compared to skeletal survey as the gold standard
Description
Diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of thermal imaging compared to the full skeletal survey as gold standard
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Potential radiation dose reduction - calculated on the basis of known radiation exposure of the images that form the skeletal survey
Description
Radiation dose saving of a protocol that only images those areas of abnormality seen on thermal imaging compared to the full skeletal survey as gold standard
Time Frame
6 months
Title
Carer acceptability/preference of the imaging modalities
Description
Descriptive statistics based on responses to a non-validated questionnaire on carer experiences of both imaging techniques
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse
Healthy Control children
Exclusion Criteria:
1. Informed consent withheld by main carer/guardian for the skeletal survey (court order would then be issues) 2. Informed consent for participation in the research study withheld 2. Situations where informed consent cannot be obtained (e.g. inability of carer/guardian to understand written English) 3. Postmortem cases (inclusion of the demised would unduly complicate the consent process for this small pilot study)
Facility Information:
Facility Name
Clinical Research Facility
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2TH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years
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