Echographic Measurement of Skin Thickness in Children (PIDIC-1)

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

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

Study Overview

• Status: Completed
• Conditions: Skin Thickness
• Intervention / Treatment: Other: Echographic measurement of skin thickness

• Study Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2018
    • Child & Family (Dutch: Kind&Gezin) Antwerp
  • Antwerp, Belgium
    • primary and secundary schools in Antwerp, Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be recruited in the vicinity of the university and its university hospital of Antwerp. Through primary and secundary school in Antwerp, children will be recruited after approval of their parents and via some Child and Family (Dutch: Kind&Gezin) facilities children aged 8 weeks to 3 years will recruited.

All recruitement will be done from October 2015 until November 15th 2015.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
participants aged 8 weeks to 3 years; 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; (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.
participants aged 3 to 6 years; 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; (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.
participants aged 6 to 12 years; 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; (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.
participants aged 12 to 18 years; 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; (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novosanis NV
• Investigators: Principal Investigator: Vanessa Vankerckhoven, PhD, CEO

Publications and helpful links

General Publications

• Van Mulder TJS, Van Nuffel D, Demolder M, De Meyer G, Moens S, Beyers KCL, Vankerckhoven VVJ, Van Damme P, Theeten H. Skin thickness measurements for optimal intradermal injections in children. Vaccine. 2020 Jan 22;38(4):763-768. doi: 10.1016/j.vaccine.2019.11.002. Epub 2019 Nov 22.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: skin thickness; high-frequency ultrasound
• Other Study ID Numbers: 2015_NOV_VX_003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No