Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years

NCT ID: NCT04237454

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-04-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Infrared Imaging undertaken

Group Type: EXPERIMENTAL

Thermal Imaging Camera

Intervention Type: DEVICE

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

Interventions

Thermal Imaging Camera

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheffield Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Facility

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

SCH-13-067f

Identifier Type: -

Identifier Source: org_study_id