Ultrasonographic Reference Values for Peripheral Nerves in Children

Normal Values of Peripheral Nerves in Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570802
• Other study ID #: Nerve US Children 01
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Patricia Hafner, MD
• Phone: +41617042272
• Email: patricia.hafner[@]ukbb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Normal Values of Peripheral Nerves in Healthy Children

Intervention

Procedure:
• Ultrasonographic examination

Locations

Country	Name	City	State
Switzerland	University of Basel, Children's Hospital	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Interrater reliability	Reliability is expressed by the intraclass correlation coefficient (ICC)	one year
Secondary	Intrarater reliability	Reliability is expressed by the intraclass correlation coefficient (ICC)	one year