Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04237454
Other study ID # SCH-13-067f
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date April 11, 2017

Study information

Verified date January 2020
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date April 11, 2017
Est. primary completion date April 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Thermal Imaging Camera
To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse

Locations

Country Name City State
United Kingdom Clinical Research Facility Sheffield South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
See also
  Status Clinical Trial Phase
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Unknown status NCT02013986 - Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children Phase 4
Terminated NCT01248182 - Bone to Skin Thickness Study: Obese Versus Normal Population N/A
Recruiting NCT00969839 - NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures Phase 4
Completed NCT00115180 - Racial and Ethnic Disparities in Acute Pain Control N/A
Completed NCT00520442 - Acute Pediatric Fracture Analgesia Study N/A
Not yet recruiting NCT06402292 - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute N/A
Recruiting NCT04947722 - The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care N/A
Recruiting NCT06107699 - The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures N/A
Completed NCT04532580 - Clinical Validation of Boneview for FDA Submission
Recruiting NCT05002335 - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Completed NCT02591043 - Surgical Treatment of Low Energy Pelvic Fractures in the Elderly N/A
Completed NCT02933359 - Osteogenic Profiling of Normal Calvarial Bone
Completed NCT01049191 - Bone Microarchitecture in Women With and Without Fracture N/A
Completed NCT03431857 - Multi Centre Study on TESS V2 Shoulder System
Recruiting NCT04133103 - Early Mobilisation in the Surgical Robot Assisted Spinal Surgery N/A
Completed NCT03993691 - Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System N/A
Active, not recruiting NCT01719887 - Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial N/A
Completed NCT02786498 - Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing Phase 2