NCT02775669

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

May 10, 2016

Last Update Submit

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:

  • closed fontanel No Need of ICP monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 1, 2015

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

May 18, 2016

Record last verified: 2016-05