Ultrasonographic Reference Values for Peripheral Nerves in Children

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess normal values of the cross-sectional area of peripheral nerves and nerve roots in children and adolescents between 2 and 18 years.

Detailed Description
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This is a single center prospective clinical trial to determine standard values of the cross-sectional area of the median, ulnar, radial, peroneal, tibial, sural and vagus nerve as well as C5, C6 and C7 cervical roots in a cohort of neuromuscular unaffected children and adolescents between 2 and 18 years.

Official Title
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Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents

Conditions
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Normal Values of Peripheral Nerves in Healthy Children

Intervention / Treatment
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* Procedure: Ultrasonographic examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents between 2 and 18 years Written informed consent of the caregivers and the children/adolescents between 14 and 18 years Exclusion Criteria: Inability to meet study requirements Neuromuscular disease or symptoms

Ages Eligible for Study
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Minimum Age: 2 Years
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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ultrasound of peripheral nerves<br>Ultrasonographic examination | Procedure: Ultrasonographic examination<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the C6 cervical root in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the C7 cervical root in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the radial nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the superficial radial nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the peroneal nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the tibial nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the sural nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 
| Cross-sectional area (mm2) of the vagus nerve in children and adolescents from 2 to 18 years | Cross-sectional area will be displayed as percentiles according age, weight and length | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interrater reliability | Reliability is expressed by the intraclass correlation coefficient (ICC) | one year | 
| Intrarater reliability | Reliability is expressed by the intraclass correlation coefficient (ICC) | one year |