HydrocephalusNCT02775669
Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
An observational study of Hydrocephalus, run by University Clinic Frankfurt.
Trial summary
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis. Read more about this study
- Who is it for?
- Ages 1 day to 15 months
- Conditions the study is for
- Hydrocephalus
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- Phase
- Observational
- 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 1 day to 15 months
- All sexes
- No healthy volunteers
- Child
Study population: Study Population: Children with open fontanels and need of intracranial pressure monitoring
Who may be able to join
- Child with open fontanel Need of ICP monitoring
Who cannot join
- closed fontanel No Need of ICP monitoring
About this study
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.
Read the detailed description
The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.
- Conditions
- Hydrocephalus
- Keywords
- noninvasive ICP monitoring
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intracranial ICP monitoring | invasive intracranial ICP monitoring | |
| tranfontanel ICP monitoring | Noninvasive transfontanel ICP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe.
ICP values in mmHg will be collected in both arms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedjan Behmanesh, University Clinic Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775669
- Sponsor's protocol ID
- 34/15
- Status last verified
- May 2016
- First submitted
- 10 May 2016
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique
- ClinicalTrials.gov ID
- NCT02775669
- Acronym / sponsor ID
- 34/15
- Conditions
- Hydrocephalus
- Keywords
- noninvasive ICP monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 May 2016 (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.
Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.
Detailed description
The investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation and Implantation of an external ventricle drain or a subdural ICP Monitoring devise. The second ICP probe is fixed epicutaneously on the skin over the frontal fontanel. The hourly measured ICPs within 24 hours postoperatively were compared with the Bland-Altman two methods analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracranial ICP monitoring | – | –invasive intracranial ICP monitoring |
| tranfontanel ICP monitoring | – | –Noninvasive transfontanel ICP monitoring |
Who may qualify
- Ages
- 1 day to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study Population: Children with open fontanels and need of intracranial pressure monitoring
Key inclusion criteria (1 listed)
- Child with open fontanel Need of ICP monitoring
Key exclusion criteria (1 listed)
- closed fontanel No Need of ICP monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe.
Time frame: 24 hours
ICP values in mmHg will be collected in both arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by University Clinic Frankfurt.
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 1 inclusion and 1 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 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ICP values (mmHg), intracranial pressure obtained invasive and noninvasive in mmHg will be compared. Either there is a significant difference or not. The data will be collected hourly. Device: Spiegelberg ICP Probe. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2016.