CClinicalTrials.gg
Status unknownNCT02775669Updated May 18, 2016

Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique

An observational study in Hydrocephalus, sponsored by University Clinic Frankfurt. Status unknown. Open to participants aged 1 Day to 15 Months. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by University Clinic Frankfurt · Observational

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
1 Day to 15 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hydrocephalus

Browse trials for

Keywords

  • noninvasive ICP monitoring
03

In context

Hydrocephalus

210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 98 observational studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

University Clinic Frankfurt is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 15 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study Population: Children with open fontanels and need of intracranial pressure monitoring

Inclusion criteria

Child with open fontanel Need of ICP monitoring

Exclusion criteria

Exclusion Criteria:

closed fontanel No Need of ICP monitoring

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • intracranial ICP monitoring

    invasive intracranial ICP monitoring

  • tranfontanel ICP monitoring

    Noninvasive transfontanel ICP monitoring

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02775669
Lead sponsor
University Clinic Frankfurt
Responsible party
Bedjan Behmanesh (MD, University Clinic Frankfurt) — Principal investigator
First posted
May 17, 2016
Start date
Jan 2015
Primary completion
Apr 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
May 18, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion