Clinical trial NCT04237454: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Abuse Physical
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Thermal Imaging
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: Diagnostic accuracy of thermal imaging for fracture detection compared to skeletal survey as the gold standard
timeFrame: 6 months
Secondary outcomes:
measure: Potential radiation dose reduction - calculated on the basis of known radiation exposure of the images that form the skeletal survey
timeFrame: 6 months
measure: Carer acceptability/preference of the imaging modalities
timeFrame: 6 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Clinical Research Facility
state: South Yorkshire
Study officials:
References: