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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

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE October 7, 2015
Last Update Posted Date December 2, 2020
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasonographic Reference Values for Peripheral Nerves in Children
Official Title  ICMJE Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Normal Values of Peripheral Nerves in Healthy Children
Intervention  ICMJE Procedure: Ultrasonographic examination
Study Arms  ICMJE ultrasound of peripheral nerves
Ultrasonographic examination
Intervention: Procedure: Ultrasonographic examination
Publications * Rasenack M, Décard BF, Schädelin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
255
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Patricia Hafner, MD +41617042272 patricia.hafner@ukbb.ch
Contact: Maria Rasenack, MD +41612652525 maria.rasenack@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02570802
Other Study ID Numbers  ICMJE Nerve US Children 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE University Children's Hospital Basel
Investigators  ICMJE
Principal Investigator: Dirk Fischer, MD University of Basel, Children's Hospital
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP