Optic Nerve Sheath Diameter in Craniosynostosis (ONSD)

October 11, 2018 updated by: Hee-Soo Kim, Seoul National University Hospital

Changes of Optic Nerve Sheath Diameter in Modified Prone Position in Craniosynostosis Children

Changes of optic nerve sheath diameter after position changes

Study Overview

Status

Completed

Detailed Description

Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children for correction of craniosyostosis

Description

Inclusion Criteria:

  • craniosynostosis

Exclusion Criteria:

  • infection on eye area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
optic nerve sheath diameter
Time Frame: 10 minutes after prone position
optic nerve sheath diameter measure with ultrasound
10 minutes after prone position

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2017

Primary Completion (Actual)

June 17, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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