- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131245
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
Conditions
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
-
-
Jongro Gu
-
Seoul, Jongro Gu, Korea, Republic of, 15710
- SNUH
-
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- H1703-147-840
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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