Ultrasonographic Reference Values for Peripheral Nerves in Children

NCT ID: NCT02570802

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2024-12-31

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.

Conditions

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Normal Values of Peripheral Nerves in Healthy Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ultrasound of peripheral nerves

Ultrasonographic examination

Group Type OTHER

Ultrasonographic examination

Intervention Type PROCEDURE

Interventions

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Ultrasonographic examination

Intervention Type PROCEDURE

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk Fischer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Children's Hospital

Locations

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University of Basel, Children's Hospital

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Patricia Hafner, MD

Role: CONTACT

+41617042272

Maria Rasenack, MD

Role: CONTACT

+41612652525

Facility Contacts

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Patricia Hafner, MD

Role: primary

+41617042272

Maria Rasenack, MD

Role: backup

+41612652525

References

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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.

Reference Type DERIVED
PMID: 27940636 (View on PubMed)

Other Identifiers

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Nerve US Children 01

Identifier Type: -

Identifier Source: org_study_id

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