Clinical trial NCT02570802: Ultrasonographic Reference Values for Peripheral Nerves in Children
Official title: Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal Values of Peripheral Nerves in Healthy Children
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2015-10-07
Enrollment: 255
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the C6 cervical root in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the C7 cervical root in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the radial nerve in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the superficial radial nerve in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the peroneal nerve in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the tibial nerve in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the sural nerve in children and adolescents from 2 to 18 years
timeFrame: one year
measure: Cross-sectional area (mm2) of the vagus nerve in children and adolescents from 2 to 18 years
timeFrame: one year
Secondary outcomes:
measure: Interrater reliability
timeFrame: one year
measure: Intrarater reliability
timeFrame: one year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Children's Hospital
Study officials:
affiliation: University of Basel, Children's Hospital
name: Dirk Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasenack M, Decard BF, Schadelin S, Grimm A, Fischer D, Hafner P. Ultrasonographic reference values for peripheral nerves and nerve roots in the normal population of children and adolescents: study protocol for an observational-prospective trial. BMJ Open. 2016 Dec 9;6(12):e014662. doi: 10.1136/bmjopen-2016-014662.