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Determination of Normal Measures of Optic Nerve Sheath Diameter in Children

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ClinicalTrials.gov Identifier: NCT03178760
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ozlem Tolu Kendir, Cukurova University

Tracking Information
First Submitted Date June 4, 2017
First Posted Date June 7, 2017
Last Update Posted Date July 16, 2020
Actual Study Start Date June 15, 2020
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2017)
Measurement of optic nerve sheath diameter [ Time Frame: 1-3 minute ]
mm
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Official Title Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Brief Summary The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.
Detailed Description

The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .

  1. Age
  2. Gender
  3. Length (cm)
  4. Weight (kg)
  5. Waist Circumference (cm)
  6. Body Mass Index
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population all patients without cerebral edema applied the emergency care unit.
Condition Optic Papilla Edema
Intervention Diagnostic Test: Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.

Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for;

  1. Age
  2. Gender
  3. Weight
  4. Length
  5. Waist Circumference
  6. Body mass index
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 15, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

• Children without cerebral edema.

Exclusion Criteria:

• Children with cerebral edema.

Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Measurements will be classified with gender.
Ages 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03178760
Other Study ID Numbers AU-70904504/393-19.06.2020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ozlem Tolu Kendir, Cukurova University
Study Sponsor Cukurova University
Collaborators Not Provided
Investigators Not Provided
PRS Account Cukurova University
Verification Date July 2020