High-resolution infrared imaging to detect bone, joint and soft-tissue infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot observational project uses High Resolution Infrared Thermographic Imaging (HRTI) to capture a 10-second thermal video of a suspected infected region in children presenting with possible musculoskeletal infection. The recorded videos will be processed and interpreted for temperature patterns that may indicate infection alongside routine clinical assessment and tests. Participation does not alter standard clinical care and is limited to patients at Sheffield Children's Hospital who can provide assent or have a guardian provide consent. The study aims to determine whether HRTI is a feasible, non-invasive adjunct for earlier detection of pediatric musculoskeletal infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children and young people from neonates to 15 years of age:
* With clinical suspicion of a primary MSK infection (irrespective of location or aetiology), as defined by presenting symptoms, physical examination and bloodwork performed by a qualified clinician.
* Presenting to Sheffield Children's Hospital via A\&E or referral from another hospital.
* Who are able to interpret the information given in the information sheet/assent form on paper in English (with the exception of children under the age of 3 years who are not required to assent.)
* With at least 1 competent legal guardian who is capable of legally consenting, and interpreting the information given in the information sheet in English.
* Where a medical doctor involved in their care has agreed that their participation in the study will not negatively impact on their treatment outcome

Exclusion Criteria:

* \- Have a secondary MSK infection.
* Are severely ill or need urgent/critical attention or have comorbid conditions that will complicate their care, as decided by a medical doctor involved in their treatment.
* Patients with conditions including but not limited to leukaemia, hyper/hypothyroidism, diabetes mellitus or any other condition that affects their basal metabolic rate/body temperature.
* Amputees where the amputated region is contralateral to the region of suspected infection.
* Have received an a priori diagnosis or have already undergone any investigation. This includes patients admitted for a recurrence/exacerbation of recently diagnosed MSK infection.
* Any patient where the medical team responsible for their treatment raises concerns that HRTI could negatively impact their treatment outcome.
* The patient, or their legal guardian(s) do not consent or assent/withdraw consent or assent/ or are not able to consent or assent for any reason. (Eg. The patient/guardian(s) are non-English speakers or have disabilities impairing their understanding of the study.)

Where it's running

• Sheffield Children's NHS Foundatin Trust
  Sheffield, South Yorkshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Sanjeev Madan
• Email: s.madan@sheffield.ac.uk
• Phone: +44 0114 271 7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.