Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years

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

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.

Study Overview

• Status: Completed
• Conditions: Fracture; Abuse Physical
• Intervention / Treatment: Device: Thermal Imaging Camera

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2TH
      • Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Infrared Imaging undertaken	Device: Thermal Imaging Camera; To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Carer acceptability/preference of the imaging modalities	Descriptive statistics based on responses to a non-validated questionnaire on carer experiences of both imaging techniques	6 months

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): April 11, 2017
• Study Completion (ACTUAL): April 11, 2017

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: SCH-13-067f

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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