NCT02775669

Unknown

Non-invasive Epicutaneous Transfontanel Intracranial Pressur...

University Clinic Frankfurt Source

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Other study identifiers

Sponsor study identifier

34/15

Study Type

observational

Estimated enrollment

10

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 10 participants
Study completion date: December 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2015
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
May 10, 2016
Actual (reported)
First Posted
May 17, 2016
Actual (reported)
Primary Completion
April 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2017
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 18, 2016
Status Verified: May 2016
Last Update Submitted: May 17, 2016

Conditions

Hydrocephalus

Keywords

noninvasive ICP monitoring

Outcome Measures

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
24 hours

Study Arms (2)

intracranial ICP monitoring

invasive intracranial ICP monitoring

tranfontanel ICP monitoring

Noninvasive transfontanel ICP monitoring

Eligibility Criteria

Age1 Day - 15 Months

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Child with open fontanel Need of ICP monitoring

You may not qualify if:

Sponsors & Collaborators

University Clinic Frankfurt
Otherlead

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 17, 2016

Study Start

January 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2017

Estimated (date passed)

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NCT02737163

Strata Programmable CSF Shunt Valve Study

Terminated

closed fontanel No Need of ICP monitoring

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

December 2017

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 18, 2016

Record last verified: 2016-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02775669
Data provider: ClinicalTrials.gov
Source updated: 2016-05-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:59 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

intracranial ICP monitoring

tranfontanel ICP monitoring

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record