Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years

NCT04237454 | Completed

• 1 other identifier: SCH-13-067f
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture; Abuse Physical

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (2)

• Potential radiation dose reduction - calculated on the basis of known radiation exposure of the images that form the skeletal survey

  6 months

• Carer acceptability/preference of the imaging modalities

  6 months

Study Arms (1)

Infrared Imaging undertaken

EXPERIMENTAL

Device: Thermal Imaging Camera

Interventions

Thermal Imaging Camera DEVICE

To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse

Infrared Imaging undertaken

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between 1 month and 2 years of age having initial/follow-up skeletal survey for investigation of suspected abuse
• Healthy Control children

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Clinical Research Facility

Sheffield, South Yorkshire, S10 2TH, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thermal Imaging

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 23, 2020
• Study Start: September 1, 2016
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)