NCT03131245

Brief Summary

Changes of optic nerve sheath diameter after position changes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

April 19, 2017

Last Update Submit

October 11, 2018

Conditions

Optic Nerve Sheath Diameter

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter

    optic nerve sheath diameter measure with ultrasound

    10 minutes after prone position

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children for correction of craniosyostosis

You may qualify if:

  • craniosynostosis

You may not qualify if:

  • infection on eye area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 27, 2017

Study Start

June 23, 2017

Primary Completion

June 17, 2018

Study Completion

July 31, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)