Ultrasonographic Reference Values for Peripheral Nerves in Children

Not Applicable

Recruiting

• Conditions: Normal Values of Peripheral Nerves in Healthy Children
• Interventions: Procedure: Ultrasonographic examination

• Registration Number: NCT02570802
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-09-14
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultrasound of peripheral nerves	Ultrasonographic examination	Ultrasonographic examination

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Interrater reliability	one year	Reliability is expressed by the intraclass correlation coefficient (ICC)
Intrarater reliability	one year	Reliability is expressed by the intraclass correlation coefficient (ICC)

Trial Locations

Locations (1)

University of Basel, Children's Hospital; 🇨🇭 Basel, Switzerland