Ultrasonographic Reference Values for Peripheral Nerves in Children

Overview

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.

Full Title of Study: “Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2021

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.

Interventions

  • Procedure: Ultrasonographic examination

Arms, Groups and Cohorts

  • Other: ultrasound of peripheral nerves
    • Ultrasonographic examination

Clinical Trial Outcome Measures

Primary Measures

  • Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: one year
    • Cross-sectional area will be displayed as percentiles according age, weight and length

Secondary Measures

  • Interrater reliability
    • Time Frame: one year
    • Reliability is expressed by the intraclass correlation coefficient (ICC)
  • Intrarater reliability
    • Time Frame: one year
    • Reliability is expressed by the intraclass correlation coefficient (ICC)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • University Children’s Hospital Basel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dirk Fischer, MD, Principal Investigator, University of Basel, Children’s Hospital
  • Overall Contact(s)
    • Patricia Hafner, MD, +41617042272, patricia.hafner@ukbb.ch

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.