Comparison of Brain Volumes Measured by 2D USG and MRI

January 12, 2021 updated by: Fuat Emre Canpolat, Ankara City Hospital Bilkent

Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging

Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

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

Study Contact

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

1 day to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Preterm infants under 32 weeks of GA and 800-1200 gram BW all admitted to Ankara Şehir Hospital MH5 NICU

Description

Inclusion Criteria:

  • All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams
  • Born in our hospital
  • Alive during discharge

Exclusion Criteria:

  • congenital anomalies
  • cranial bleeding
  • early death

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of two different brain volumes
Time Frame: 6 months
Patients in cohort will have both USG and cranial MRI
6 months

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Chair: Mustafa Şenol Akın, MD, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2019

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019512-1

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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