Normal Values of Peripheral Nerves in Healthy ChildrenNCT02570802
Ultrasonographic Reference Values for Peripheral Nerves in Children
A study testing Ultrasonographic examination in people with Normal Values of Peripheral Nerves in Healthy Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Values of Peripheral Nerves in Healthy Children
- What is being tested?
- Ultrasonographic examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children and adolescents between 2 and 18 years
- Written informed consent of the caregivers and the children/adolescents between 14 and 18 years
Who cannot join
- Inability to meet study requirements
- Neuromuscular disease or symptoms
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Basel, Children's Hospital
Basel, 4056
Patricia Hafner, MD, +41617042272, patricia.hafner@ukbb.ch
Maria Rasenack, MD, +41612652525, maria.rasenack@usb.ch
About this study
Official title: Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents
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.
Read the 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.
- Being tested
- Ultrasonographic examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examinationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ultrasound of peripheral nerves | Other | Ultrasonographic examination Receives: Procedure: Ultrasonographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
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
Measured: one year
Secondary outcomes (2)
Interrater reliability
Reliability is expressed by the intraclass correlation coefficient (ICC)
Measured: one year
Intrarater reliability
Reliability is expressed by the intraclass correlation coefficient (ICC)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Values of Peripheral Nerves in Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Dirk Fischer, MD, Principal investigator, University of Basel, Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570802
- Sponsor's protocol ID
- Nerve US Children 01
- Status last verified
- May 2024
- First submitted
- 14 Sep 2015
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27940636
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Reference Values for Peripheral Nerves and Nerve Roots in the Normal Population of Children and Adolescents
- ClinicalTrials.gov ID
- NCT02570802
- Acronym / sponsor ID
- Nerve US Children 01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- Oct 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound of peripheral nerves | Other | Procedure: Ultrasonographic examinationUltrasonographic examination |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children and adolescents between 2 and 18 years
- Written informed consent of the caregivers and the children/adolescents between 14 and 18 years
Key exclusion criteria (2 listed)
- Inability to meet study requirements
- Neuromuscular disease or symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic examination | Procedure or surgery | ultrasound of peripheral nerves |
Primary outcome
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
2 secondary outcomes
Interrater reliability
Time frame: one year
Intrarater reliability
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 27940636Rasenack 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Fischer, MD principal investigator
University of Basel, Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic examination in people with Normal Values of Peripheral Nerves in Healthy Children, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Hafner, MD (+41617042272, patricia.hafner@ukbb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area (mm2) of the C5 cervical root in children and adolescents from 2 to 18 years (time frame: one year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.