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NCT02775669 Clinical Trial

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

Hydrocephalus Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02775669
Other study ID # 34/15
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 10, 2016
Last updated May 17, 2016
Start date January 2015
Est. completion date December 2017

Study information
Verified date May 2016
Source University Clinic Frankfurt
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Investigators compare the ICP of two standard Spiegelberg ICP-probes in children, which underwent an operation due to craniosynostosis.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date December 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group N/A to 15 Months
Eligibility Inclusion Criteria:

Child with open fontanel Need of ICP monitoring

Exclusion Criteria:

closed fontanel No Need of ICP monitoring

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Clinic Frankfurt

Outcome
Type Measure Description Time frame Safety issue
Primary 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 24 hours Yes
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