Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
259 participants
OBSERVATIONAL
2016-02-29
2017-07-31
Brief Summary
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Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer
Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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
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
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age: 8 weeks to 18 years
* Dutch-speaking
* Caucasian
Exclusion Criteria
* Suffering from skin diseases (psoriasis, burning wounds)
* Pregnancy or lactating
8 Weeks
18 Years
ALL
Yes
Sponsors
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Novosanis NV
INDUSTRY
Responsible Party
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Principal Investigators
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Vanessa Vankerckhoven, PhD
Role: PRINCIPAL_INVESTIGATOR
CEO
Locations
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University of Antwerp
Wilrijk, Antwerp, Belgium
Child & Family (Dutch: Kind&Gezin) Antwerp
Antwerp, , Belgium
primary and secundary schools in Antwerp, Belgium
Antwerp, , Belgium
Countries
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References
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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.
Other Identifiers
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2015_NOV_VX_003
Identifier Type: -
Identifier Source: org_study_id