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Ultrasonographic Reference Values for Peripheral Nerves in Children

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ClinicalTrials.gov Identifier: NCT02570802
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Normal Values of Peripheral Nerves in Healthy Children Procedure: Ultrasonographic examination Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents
Study Start Date : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
ultrasound of peripheral nerves
Ultrasonographic examination
 Procedure: Ultrasonographic examination


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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 Outcome Measures :
  1. Interrater reliability [ Time Frame: one year ]
    Reliability is expressed by the intraclass correlation coefficient (ICC)

  2. Intrarater reliability [ Time Frame: one year ]
    Reliability is expressed by the intraclass correlation coefficient (ICC)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570802


Contacts
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Contact: Patricia Hafner, MD +41617042272 patricia.hafner@ukbb.ch
Contact: Maria Rasenack, MD +41612652525 maria.rasenack@usb.ch

Locations
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Switzerland
University of Basel, Children's Hospital Recruiting
Basel, Switzerland, 4056
Contact: Patricia Hafner, MD    +41617042272    patricia.hafner@ukbb.ch   
Contact: Maria Rasenack, MD    +41612652525    maria.rasenack@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Investigators
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Principal Investigator: Dirk Fischer, MD University of Basel, Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02570802    
Other Study ID Numbers: Nerve US Children 01
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020