Echographic Measurement of Skin Thickness in Children

Study Overview
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Brief Summary
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To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of children (aged 8 weeks to 18 years) using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI. Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer

Official Title
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Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents

Conditions
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Skin Thickness

Intervention / Treatment
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* Other: Echographic measurement of skin thickness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children Age: 8 weeks to 18 years Dutch-speaking Caucasian Exclusion Criteria: Using ointment, crème, gels or oral medication based on corticoids Suffering from skin diseases (psoriasis, burning wounds) Pregnancy or lactating

Ages Eligible for Study
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Minimum Age: 8 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| participants aged 8 weeks to 3 years<br>Echographic measurement of skin thickness at the proximal forearm, the deltoid region and medial thigh (till age of 2 years) in participants aged 8 weeks to 3 years. aimed number: 32 boys & 32 girls / maximum number: 50 boys & 50 girls | Other: Echographic measurement of skin thickness<br>* (Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.<br>|
| participants aged 3 to 6 years<br>Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 3 to 6 years. aimed number: 32 boys & 32 girls / maximum number: 50 boys & 50 girls | Other: Echographic measurement of skin thickness<br>* (Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.<br>|
| participants aged 6 to 12 years<br>Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 6 to 12 years. aimed number: 32 boys & 32 girls / maximum number: 50 boys & 50 girls | Other: Echographic measurement of skin thickness<br>* (Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.<br>|
| participants aged 12 to 18 years<br>Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 12 to 18 years. aimed number: 32 boys & 32 girls / maximum number: 50 boys & 50 girls | Other: Echographic measurement of skin thickness<br>* (Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin thickness (in millimeters) of the proximal dorsal forearm (both left and right) |  | 5-10 minutes | 
| skin thickness (in millimeters) of the proximal ventral forearm (both left and right) |  | 5-10 minutes | 
| skin thickness (in millimeters) of the deltoid region (both left and right) |  | 5-10 minutes | 
| skin thickness (in millimeters) of the medial thigh region (both left and right) |  | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin thickness, high-frequency ultrasound