# Infrared Thermal Imaging Analysis in Screening for Toddler's Fracture: A Proof-of-Concept Study
## 2 Materials and Methods
### Recruitment  
Ethical approval for the study was attained from the UK National Health Service Ethics Committee (REC Reference 20/SS/0124, IRAS project ID 280774). The study was registered on clinicaltrials.org (NCT05536622). A participant information sheet for the parents, and its simplified version for their children aged 3-5 years, were prepared. For children aged 3-5 years, the parents consented and the child assented. For children younger than 3 years, only their parents consented. The participants' personal data and their infrared thermal imaging were anonymized prior to storage and processing in accordance with the UK Data Protection Act (2018). Participants were recruited from an urban tertiary pediatric emergency department (ED) who attended with suspicion of a toddler's fracture. The inclusion criteria were:  
* Children aged up to 5 years (inclusive) admitted to the emergency department (ED) of Sheffield Children's Hospital for a leg injury suspected of a toddler's fracture;
* Triaged as category D (excluding those in severe pain, or deformity);* Children who were X-rayed as part of their routine assessment (no patient underwent an X-ray for the purpose of this study);
* Consent by parents and assent by the child (in cases of a child aged 3 years and older);
* The exclusion criteria were:
* Participants who had multiple injuries (e.g., those involved in a serious car accident);
* Participants who had difficulty understanding the nature of the study (e.g., non-native English speakers, or those with disabilities impairing their understanding of the study);
* Participants whose consent (parent) or assent (child) could not be obtained. Altogether, 46 participants were recruited; however, in seven cases, the child was too uncooperative for recording (e.g., excessive leg movements during recording), thus their data were excluded. The analysis was based on 39 participants, eight with a toddler's fracture (confirmed by X-ray radiograph) and, for the remaining 31 cases, X-ray radiograph had not shown a fracture. Table 1 provides the details of the 39 participants included in the study. The details of the participants with a toddler's fracture are included in Table 2. \begin{table}
\begin{tabular}{c c c} \hline \hline
**Demographic Parameters** & **Measures** \\ \hline Diagnosis (confirmed by X-ray) & \begin{tabular}{c} 31 participants without a toddler’s fracture \\ 8 participants with a toddler’s fracture \\ \end{tabular} \\ \hline Participant age (years) & \begin{tabular}{c} Mean: 1.89 \\ Standard deviation: 1.18 \\ \end{tabular} \\ \hline Participant sex & \begin{tabular}{c} 25 males \\ 14 females \\ \end{tabular} \\ \hline Injury side & \
\begin{tabular}{c} 21 patients with injury on the right leg \\ 18 patients with injury on the left leg \\ \end{tabular} \\ \hline Medication &
\begin{tabular}{c} 17 participants on medication (paracetamol, ibuprofen) \\ 22 participants without medication \\ \end{tabular} \\ \hline \hline \end{tabular}
\end{table} 
Table 1: Characteristics of study participants. \begin{table}
\begin{tabular}{c c c c c c c} \hline \hline
**Toddler’s Fracture** & **Age** & **Sex** & **Injured Leg** & **Fracture Details** & **Fracture Confirmation** & **Medication** \\ \hline \multirow{3}{*}{1} & \multirow{3}{*}{2 (2)} & \multirow{3}{*}{Male} & \multirow{3}{*}{Right} & \begin{tabular}{c} Trampoline fracture, \\ non-displaced \\ transvers right proximal \\ tibial fracture \\ \end{tabular}  & Second visit & Nil \\ \cline{1-1} \cline{3-8}  & & & & \begin{tabular}{c} Un-displaced transverse \\ fracture tibial \\ metaphysis \\ \end{tabular}  & First visit & Paracetamol \\ \hline \multirow{3}{*}{3} & \multirow{3}{*}{2 (2)} & \multirow{3}{*}{Male} & \multirow{3}{*}{Left} & \begin{tabular}{c} Spiral fracture of the tibia, \\ buckle fracture of the \\ proximal fibula \\ \end{tabular}  & First visit & Ibuprofen \\ \cline{1-1} \cline{3-8}  & & & & \begin{tabular}{c} Distal toddler’s fracture \\ fracture \\ \end{tabular}